Impco Disposable Aortic Punch
FDA 510(k) K780247 · Thoratec Laboratories Corp.
510(k) numberK780247
Submission
- Device name
- Impco Disposable Aortic Punch
- Applicant
- Thoratec Laboratories Corp.
Walker, MI, US - Received
- February 13, 1978
- Decision date
- February 27, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWS – Instruments, Surgical, Cardiovascular
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4500
- Specialty
- Cardiovascular
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|---|---|---|---|
| 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 |
More from Bio-Vascular, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K001927 | Vectra (TM) Vascular Access GRAFT-5MM DIAMETER,6MM Diameter and Vectra (TM) Vascular…DSY · Traditional | 12/18/2000SE |
| K001926 | Vascular Graft Tunneler-Standard Curve, Mid Curve, Full Curve, Short Standard Curve…DYB · Traditional | 09/22/2000SE |
| K851495 | Thoratec Multilumen Central Venous Cath-Tray · Traditional | 08/01/1985SESD |
| K833714 | Respiratory Assessment SystemBZL · Traditional | 12/29/1983SE |
| K833265 | Respiratory Flow ModuleJAX · Traditional | 11/28/1983SE |
| K831557 | Intraoperative Autotransfusion SysCAC · Traditional | 08/24/1983SE |
| K823449 | Respiratory Gas AnalyzerCCL · Traditional | 01/05/1983SE |
| K823287 | Respiratory Circuit AdaptorBZO · Traditional | 12/09/1982SE |
| K822769 | Thoratec Gas Sampling ConnectorCAI · Traditional | 10/06/1982SE |
Questions and answers
When was Impco Disposable Aortic Punch cleared by the FDA?
Impco Disposable Aortic Punch (K780247) received a 510(k) decision of Substantially Equivalent on February 27, 1978, 14 days after the submission was received.
What is the product code of K780247?
The FDA product code is DWS – Instruments, Surgical, Cardiovascular, a Class I (low risk) device regulated under 21 CFR 870.4500.