Trocar
FDA product code DRC · Class II (moderate risk) · 21 CFR 870.1390 · Cardiovascular
51510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Pressure Products Medical Device Manufacturing, LLC 7
- Medical Device Technologies, Inc. 3
- North American Instrument Corp. 3
- Advance Medical Designs, Inc. 2
- Heartport, Inc. 2
- Medcanica, Inc. 2
- St Jude Medical 2
- Oscor, Inc. 2
- Synaptic Medical Corporation 2
- E-Z-Em, Inc. 2
- Medsurg Industries, Inc. 2
- Great Batch Medical 2
- United States Surgical, A Division of Tyco Healthc 1
- Sterimed, Inc. 1
- Applied Medical 1
- United States Endoscopy Group, Inc. 1
- Shanghai Microport EP Medtech Co., Ltd. 1
- Evermed, Inc. 1
- Visitec Co. 1
- Instrumentation Laboratory CO 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240246 | Accusafe Transseptal Guidewire (GTR31180, GTR31230)DRC · Traditional | Synaptic Medical Corporation | 07/26/2024SE |
| K241042 | SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)DRC · Special | Pressure Products Medical Device Manufacturing… | 05/17/2024SE |
| K221707 | SafeSept® Transseptal Guidewire (SS-140)DRC · Special | Pressure Products Medical Device Manufacturing… | 09/14/2022SE |
| K212625 | PathBuilder Transseptal NeedleDRC · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 03/23/2022SE |
| K210328 | SafeSept Blunt NeedleDRC · Special | Pressure Products Medical Device Manufacturing… | 03/05/2021SE |
| K172950 | TSN Transseptal NeedleDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/21/2018SE |
| K172934 | Needle Free Transseptal CannulaDRC · Traditional | Pressure Products Medical Device Manufacturing… | 02/16/2018SE |
| K172893 | SafeSept Needle Free Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 12/21/2017SE |
| K170671 | SafeSept Transseptal GuidewireDRC · Traditional | Pressure Products Medical Device Manufacturing… | 10/20/2017SE |
| K132943 | Intracardic Catheter Introducer Kit and Transseptal NeedleDRC · Traditional | Synaptic Medical Limited | 08/29/2014SE |
| K130843 | Safesept Needle Free Transseptal Trocar GuidewireDRC · Traditional | Oscor, Inc. | 01/08/2014SE |
| K122587 | BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208DRC · Special | St Jude Medical | 02/07/2013SE |
| K122832 | Mobicath Transseptal NeedleDRC · Special | Great Batch Medical | 12/19/2012SE |
| K111644 | Mobicath Transseptal NeedleDRC · Traditional | Great Batch Medical | 10/03/2011SE |
| K081986 | Safesept Transseptal Trocar GuidewireDRC · Traditional | Oscor, Inc. | 11/14/2008SE |
| K072278 | BRK Transseptal NeedleDRC · Traditional | St Jude Medical | 09/13/2007SE |
| K061070 | Hansen Medical Transseptal Needle and DilatorDRC · Traditional | Hansen Medical, Inc. | 10/13/2006SE |
| K022117 | Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM) Shielded…DRC · Traditional | Merit Medical Systems, Inc. | 10/11/2002SE |
| K022257 | Vomed Peripheral Vascular Accessories, Models 1010 XXX-7090 XXX & 9006 XXX-9011 XXXDRC · Traditional | Vomed Volzer Medizintechnik GmbH & Co. | 10/04/2002SE |
| K011727 | Transseptal Needle/TrocarDRC · Traditional | Thomas Medical Products, Inc. | 05/02/2002SE |
| K011373 | Instrument Damping PortDRC · Traditional | Medcanica, Inc. | 10/12/2001SE |
| K011349 | Intercostal Lockable-Directable PortDRC · Traditional | Medcanica, Inc. | 10/05/2001SE |
| K974745 | Manan Gwi Guide Wire IntroducerDRC · Traditional | Medical Device Technologies, Inc. | 04/06/1998SE |
| K974743 | MananDRC · Traditional | Medical Device Technologies, Inc. | 04/06/1998SE |
| K974742 | Manan Potts-Cournand NeedleDRC · Traditional | Medical Device Technologies, Inc. | 04/06/1998SE |
| K964302 | Heartport Thoracic TrocarDRC · Traditional | Heartport, Inc. | 05/09/1997SE |
| K965051 | Heartport Needle TrocarDRC · Traditional | Heartport, Inc. | 03/12/1997SE |
| K951448 | Global Medical Products Potts Cournand, Seldinger Style Needle, Single, Winged Single…DRC · Traditional | Global Medical Products, Ltd. | 03/27/1996SE |
| K936247 | Medicon Instruments Trocars, Trocar Sleeves and Reduction SleevesDRC · Traditional | Medicon Instruments, Inc. | 05/19/1994SE |
| K940036 | Endosurg Disposable Secondary TrocarDRC · Traditional | Endosurg | 05/12/1994SE |
| K924338 | Arrow-Fischell Extended Vascular Access NeedleDRC · Traditional | Arrow Intl., Inc. | 03/18/1993SE |
| K913267 | R-Group Intl. One Wall Puncture NeedleDRC · Traditional | R-Group Intl. | 06/05/1992SE |
| K914985 | Disposable Angiography Needle, ModificationDRC · Traditional | E-Z-Em, Inc. | 12/20/1991SE |
| K911483 | Laparoscopic TrocarDRC · Traditional | United States Endoscopy Group, Inc. | 07/02/1991SE |
| K911462 | Surgical TrocarDRC · Traditional | Applied Medical | 04/22/1991SE |
| K900664 | Disposable Cournand, Seldinger & One-Wall NeedlesDRC · Traditional | Sterimed, Inc. | 07/18/1990SE |
| K895455 | Seldinger Percutaneous 2 PC NeedlesDRC · Traditional | Advance Medical Designs, Inc. | 11/14/1989SE |
| K895454 | Seldinger Single Wall; Style I & II (Flashback)DRC · Traditional | Advance Medical Designs, Inc. | 11/14/1989SE |
| K893707 | Auto Suture Surgiport Depth Guide and SkirtDRC · Traditional | United States Surgical, A Division of Tyco Healthc | 06/15/1989SE |
| K890209 | Disposable Angiography NeedlesDRC · Traditional | E-Z-Em, Inc. | 05/19/1989SE |
| K871377 | Namic Cournand Style Introducer NeedleDRC · Traditional | North American Instrument Corp. | 05/07/1987SE |
| K871382 | Namic One Part Introducer NeedleDRC · Traditional | North American Instrument Corp. | 05/06/1987SE |
| K871378 | Namic Seldinger Introducer NeedleDRC · Traditional | North American Instrument Corp. | 05/06/1987SE |
| K854293 | Medsurg Pott-Cournand NeedleDRC · Traditional | Medsurg Industries, Inc. | 01/15/1986SE |
| K854294 | Medsurg Seldinger NeedleDRC · Traditional | Medsurg Industries, Inc. | 01/13/1986SE |
| K853132 | Emerson Tro/Cath Trocar CathetersDRC · Traditional | J. H. Emerson Co. | 01/08/1986SE |
| K840529 | Steiger Tunneling Instrument 285DRC · Traditional | Evermed, Inc. | 03/12/1984SE |
| K811964 | Visitec Needle Range (Cardiovascular)DRC · Traditional | Visitec Co. | 07/20/1981SE |
| K781221 | Dilution Kit, Thermal, Cold PacDRC · Traditional | Instrumentation Laboratory CO | 08/23/1978SE |
| K772369 | Needles Used in Angiographic Proced.DRC · Traditional | Argon Medical Corp. | 01/24/1978SE |
| K771261 | AdvansetDRC · Traditional | C.R. Bard, Inc. | 08/16/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1526-2024 Class II | Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous…Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | Cook Incorporated | 03/01/2024Open, Classified |
| Z-0222-2022 Class II | Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product…Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be… | Cook Inc. | 10/08/2021Terminated |
| Z-1263-2021 Class II | Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an…The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip… | Merit Medical Systems, Inc. | 01/19/2021Terminated |
| Z-1262-2021 Class II | HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an…The labeled needle tip curvature of specific lots of transseptal needles may not match the actual needle tip… | Merit Medical Systems, Inc. | 01/19/2021Terminated |
| Z-0979-2019 Class I | Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For…The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside… | Cook Inc. | 02/01/2019Terminated |
| Z-1584-2018 Class II | 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length (5 count)…Products have been packaged with the wrong Trocar length type. | CooperSurgical, Inc. | 03/12/2018Terminated |
| Z-1375-2016 Class II | Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the…Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due… | Merit Medical Systems, Inc. | 03/15/2016Terminated |
| Z-0535-2015 Class II | A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or…The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market… | Instrumed International, Inc. | 09/08/2014Terminated |
| Z-0147-2015 Class II | Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the… | CooperSurgical, Inc. D.B.A. Lone Star… | 09/13/2013Terminated |
| Z-0336-2011 | ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #:…This recall has been initiated because Ethicon Endo-Surgery is aware of an increase in reports of leaking in… | Ethicon Endo-Surgery Inc | 09/27/2010Terminated |
| Z-2018-2010 | Angiotech Vascular Access Needle. A) "Modified Potts/Cournand" Needle. STERILE. Product…Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast… | Medical Device Technologies, Inc. | 09/01/2009Terminated |