Instruments, Surgical, Cardiovascular
FDA product code DWS · Class I (low risk) · 21 CFR 870.4500 · Cardiovascular
71510(k) clearances
0PMA approvals
19recalls
Manufacturers
- Manan Manufacturing Co., Inc. 3
- Pilling Co. 3
- GE Medical Systems, LLC 3
- Pioneering Technologies, Inc. 3
- Edward Weck, Inc. 3
- Sherwood Medical Industries 2
- Scanlan Intl., Inc. 2
- American V. Mueller 2
- Howmedica Corp. 2
- Cardiac Pacemakers, Inc. 2
- Medical Engineering Corp. 2
- Codman & Shurtleff, Inc. 2
- V. Mueller O.V. Baxter Healthcare Corp. 2
- Dlp, Inc. 2
- Narco Scientific 1
- Conphar, Inc. 1
- Thoratec Laboratories Corp. 1
- Hancock Laboratories, Inc. 1
- J. Jamner Surgical Instruments, Inc. 1
- Medtronic Vascular 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022238 | Myocardial Lead Implant Tool, Model 10626DWS · Traditional | Medtronic Vascular | 10/09/2002SE |
| K964445 | Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)DWS · Traditional | Dlp, Inc. | 01/30/1997SE |
| K962771 | Burke Congenital Thoracoscopy InstrumentsDWS · Traditional | Pilling Weck, Inc. | 11/19/1996SE |
| K955689 | RNS Sterile, Disposable Digital Angiographic TrayDWS · Traditional | Contour Fabricators of Florida, Inc. | 05/15/1996SE |
| K960139 | G.E. Sterile Angiographic TrayDWS · Traditional | GE Medical Systems | 04/19/1996SESK |
| K960144 | G.E. Sterile CT Biopsy TrayDWS · Traditional | GE Medical Systems | 04/15/1996SESK |
| K960143 | G.E. Sterile Digital Angiographic TrayDWS · Traditional | GE Medical Systems | 04/09/1996SESK |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 01/10/1994SE |
| K900379 | Hycult Diamond Coronary Bypass KnifeDWS · Traditional | St. Jude Medical, Inc. | 03/19/1990SE |
| K896307 | Insulation PadDWS · Traditional | Bio-Vascular, Inc. | 01/19/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | Cardiac Pacemakers, Inc. | 09/13/1989SE |
| K893436 | Modified Sterilization Method of Pti Heart-LiftDWS · Traditional | Pioneering Technologies, Inc. | 07/14/1989SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | Acacia Laboratories, Inc. | 07/14/1989SE |
| K891000 | Modified External PadDWS · Traditional | Instromedix, Inc. | 05/19/1989SE |
| K890432 | Deknatel High Precision Vascular Punch(Tm)DWS · Traditional | Deknatel, Inc. | 04/13/1989SE |
| K890707 | Phrenic Nerve Pad & Nerve Pad W/1/4 PercardialDWS · Traditional | Dlp, Inc. | 04/10/1989SE |
| K882981 | Pti Intra-Art Coronary Artery Retraction ClipDWS · Traditional | Pioneering Technologies, Inc. | 09/27/1988SE |
| K883135 | Pti Heart-Lift(Tm) Cardiac Elevator (Sterile)DWS · Traditional | Pioneering Technologies, Inc. | 09/26/1988SE |
| K882367 | Metatech Microclip ApplicatorDWS · Traditional | Metatech Corp. | 08/25/1988SE |
| K881796 | Umi Disposable Butterfly Style Puncture NeedleDWS · Traditional | Universal Medical Instrument Corp. | 07/26/1988SE |
| K882479 | 26MM Diameter Hancock* Trocar Blade and TipDWS · Traditional | Medtronic Blood Systems, Inc. | 07/18/1988SE |
| K881717 | Pti Heart-Lift(Tm) Cardiac Support Sling (Sterile)DWS · Traditional | Buckman Co., Inc. | 07/05/1988SE |
| K881392 | Cardicad(Tm)DWS · Traditional | Medical/Surgical Specialties, Ltd. | 05/31/1988SE |
| K875016 | Biosurge Model ILVC-1DWS · Traditional | Biosurge, Inc. | 02/29/1988SE |
| K874960 | Cardiovascular Surgical InstrumentsDWS · Traditional | Solway, Inc. | 02/05/1988SE |
| K864461 | Medsurg Custom Cardiovascular Procedure TrayDWS · Traditional | Medsurg Industries, Inc. | 11/24/1986SE |
| K861745 | Vickers Ergomatic Microsurg Instru Cardiac SetDWS · Traditional | Keeler Instruments, Inc. | 05/13/1986SE |
| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | Scanlan Intl., Inc. | 07/12/1985SE |
| K851834 | Manan Gwi Guide Wire IntroducerDWS · Traditional | Manan Manufacturing Co., Inc. | 07/11/1985SE |
| K851833 | Manan Seldinger NeedleDWS · Traditional | Manan Manufacturing Co., Inc. | 07/11/1985SE |
| K851832 | Naman Potts Cournand NeedleDWS · Traditional | Manan Manufacturing Co., Inc. | 07/11/1985SE |
| K851152 | MC-4000 Surgical Instruments CardiovascularDWS · Traditional | Cryomedics, Inc. | 06/24/1985SE |
| K851140 | Teleflex Medical Introducer NeedleDWS · Traditional | Teleflexmedical, Inc. | 06/19/1985SE |
| K850394 | Lemaitre Retrograde Valvulotome-Manu-Surgica InstrDWS · Traditional | Vascutech, Inc. | 04/24/1985SE |
| K844584 | Gore-Tex TunnelerDWS · Traditional | W. L. Gore & Associates, Inc. | 01/24/1985SE |
| K841468 | Pma Angiography TrayDWS · Traditional | Professional Medical Services | 06/05/1984SE |
| K840305 | Category 1 Circulatory System DeviceDWS · Traditional | Imm Enterprises , Ltd. | 04/23/1984SE |
| K833547 | Rotary Vascular KnifeDWS · Traditional | Formedco, Inc. | 01/26/1984SE |
| K831455 | Leather Valve CutterDWS · Traditional | American V. Mueller | 07/07/1983SE |
| K830471 | Kelly-Wick TannelerDWS · Traditional | Intl. Medical Prosthetics Research | 03/24/1983SE |
| K823764 | Scanlan Single-Use Aorta PunchDWS · Traditional | Scanlan Intl., Inc. | 03/24/1983SE |
| K823094 | Cardiac ElevatorDWS · Traditional | Cardio Surgical Research, Inc. | 12/15/1982SE |
| K822829 | Rotary Vascular KnifeDWS · Traditional | Medco Products, Co., Inc. | 11/17/1982SE |
| K821569 | Leather ValvulotomeDWS · Traditional | American V. Mueller | 05/27/1982SESP |
| K820258 | Deknatel Disposable Goosen Vascular PNCHDWS · Traditional | Howmedica Corp. | 03/02/1982SE |
| K813284 | Venous Cannula TrayDWS · Traditional | Cunningham Woodland, Inc. | 12/29/1981SE |
| K810890 | NeoloopsDWS · Traditional | Medical Marketing Systems | 08/31/1981SE |
| K802079 | Deknatel Goosen Vascular Punch BladesDWS · Traditional | Howmedica Corp. | 09/16/1980SE |
| K801393 | Air Aspirator NeedleDWS · Traditional | Texas Medical Products, Inc. | 06/30/1980SE |
| K800122 | Hancock Aortic PunchDWS · Traditional | Hancock Laboratories, Inc. | 02/01/1980SE |
| K792576 | Castroviejo Vascular ScissorsDWS · Traditional | Edward Weck, Inc. | 12/19/1979SE |
| K792088 | Aortic Occluder #000390DWS · Traditional | Edward Weck, Inc. | 10/26/1979SE |
| K791710 | Cardiovascular Instruments-VariousDWS · Traditional | Edward Weck, Inc. | 09/12/1979SE |
| K791370 | Silicone Surgical Vessel LoopsDWS · Traditional | Conphar, Inc. | 08/03/1979SE |
| K790124 | Graft TunnelerDWS · Traditional | Narco Scientific | 02/08/1979SE |
| K781336 | Surgitek Disposable Flo-ResterDWS · Traditional | Medical Engineering Corp. | 10/10/1978SE |
| K780567 | Aortic PumpDWS · Traditional | ETHICON, Inc. | 04/28/1978SE |
| K780247 | Impco Disposable Aortic PunchDWS · Traditional | Thoratec Laboratories Corp. | 02/27/1978SE |
| K771625 | Leiningeo Aortic Punch #310-395 & 397DWS · Traditional | J. Jamner Surgical Instruments, Inc. | 09/12/1977SE |
| K771026 | Huang Vein Holder, #21-8011DWS · Traditional | Codman & Shurtleff, Inc. | 06/20/1977SE |
| K761328 | Anastomasis OccluderDWS · Traditional | Medical Engineering Corp. | 02/01/1977SE |
| K761161 | 67-8006 Darling-Linton Aortic Tourn.DWS · Traditional | Codman & Shurtleff, Inc. | 12/06/1976SE |
| K760792 | Scissor - 1.5MM Probe Point, AngledDWS · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/11/1976SE |
| K760791 | Cooley Angled Scissor - 1MM Probe PointDWS · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 11/11/1976SE |
| K760648 | Tibial Artery Clamp W/Atraugrip JawsDWS · Traditional | Pilling Co. | 09/21/1976SE |
| K760646 | Carotid Artery Clamp W/Pilling LMMDWS · Traditional | Pilling Co. | 09/21/1976SE |
| K760645 | Carotid Artery Arteriotomy Closure ClampDWS · Traditional | Pilling Co. | 09/21/1976SE |
| K760624 | Small Vessel CannulaDWS · Traditional | Cobe Laboratories, Inc. | 09/17/1976SE |
| K760351 | Catheter, Argyle ThoracicDWS · Traditional | Sherwood Medical Industries | 08/23/1976SE |
| K760136 | Catheter, Thoracic DrainDWS · Traditional | Sherwood Medical Industries | 07/20/1976SE |
| K760087 | Tape, Vascular, 1/4 DacronDWS · Traditional | Meadox Medicals, Div. Boston Scientific Corp. | 07/20/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1736-2025 Class II | Introducer Needle REF NDL-107-04 These needles are used for the percutaneous…Due to a potential open seal in the sterile barrier packaging. | Galt Medical Corporation | 03/27/2025Open, Classified |
| Z-2513-2023 Class II | Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring…Sterility of device may be compromised due to breach of the chevron seal of the packaging | Cook Vandergrift, Inc. | 07/24/2023Open, Classified |
| Z-2274-2023 Class II | ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | Maquet Cardiovascular, LLC | 06/28/2023Open, Classified |
| Z-2273-2023 Class II | ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | Maquet Cardiovascular, LLC | 06/28/2023Open, Classified |
| Z-2272-2023 Class II | ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | Maquet Cardiovascular, LLC | 06/28/2023Open, Classified |
| Z-2271-2023 Class II | ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number…The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to… | Maquet Cardiovascular, LLC | 06/28/2023Open, Classified |
| Z-0887-2022 Class II | Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include… | Maquet Cardiovascular, LLC | 02/09/2022Open, Classified |
| Z-1483-2020 Class II | Teleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of…The sterile packaging has the potential to be compromised. | Deroyal Industries, Inc. Lafollette | 02/06/2020Terminated |
| Z-1270-2020 Class II | Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm, REF DP-28K…There is a potential for the device packaging to become compromised; thus, the sterility of the device… | Teleflex Medical Inc | 01/13/2020Terminated |
| Z-1269-2020 Class II | Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440There is a potential for the device packaging to become compromised; thus, the sterility of the device… | Teleflex Medical Inc | 01/13/2020Terminated |
| Z-1953-2018 Class II | Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1…Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the… | Genesee BioMedical, Inc. | 02/26/2018Open, Classified |
| Z-0654-2017 Class II | The Hemotherm 400CE 115v, containing power board p/n 39945The device may not maintain water flow or temperature control. | Cincinnati Sub-Zero Products Inc | 11/07/2016Terminated |
| Z-2424-2015 Class II | IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product…It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | International Biophysics Corp. | 08/07/2015Terminated |
| Z-2423-2015 Class II | IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36…It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. | International Biophysics Corp. | 08/07/2015Terminated |
| Z-1538-2014 Class II | Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument…The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage… | Biorep Technologies | 03/19/2014Terminated |
| Z-1542-2013 Class II | QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and…Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal… | Edwards Lifesciences, LLC | 05/14/2013Terminated |
| Z-1267-2013 Class II | Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide…There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use. | Symmetry Medical/SSI | 04/10/2013Terminated |
| Z-1370-2011 | MitraXs" Self Adjusting Atrial Retractor, Sterile EO, Models (REF): A0030/1; A0031/1…St. Jude Medical Cardiovascular Division is conducting a voluntary recall of all batches and model numbers… | St. Jude Medical Cardiovascular Division | 01/26/2011Terminated |
| Z-0134-2011 | Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue…Medtronic has received reports regarding the Octopus Nuvo Tissue Stabilizer stating that during use, the… | Medtronic Perfusion Systems | 09/13/2010Terminated |