Pti Anastomark(Tm) Coronary Bypass Graft Markers
FDA 510(k) K901682 · Pioneering Technologies, Inc.
510(k) numberK901682
Submission
- Device name
- Pti Anastomark(Tm) Coronary Bypass Graft Markers
- Applicant
- Pioneering Technologies, Inc.
Wheat Ridge, CO, US - Received
- April 10, 1990
- Decision date
- July 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3450
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252445 | Fusion Bioline Vascular GraftDSY · Traditional | Maquet Cardiovascular, LLC | 04/27/2026SE |
| K252277 | Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)DSY · Traditional | Vascular Flow Technologies Limited | 10/20/2025SE |
| K241550 | Gelweave Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 02/27/2025SE |
| K241070 | Gelsoft Plus Vascular ProsthesesDSY · Traditional | Vascutek, Ltd. | 11/15/2024SE |
| K231972 | Advanta VXT Vascular Graft, Flixene Vascular GraftDSY · Traditional | Atrium Medical Corporation | 03/28/2024SE |
| K240083 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 03/01/2024SE |
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular GraftsDSY · Traditional | Peca Labs, Inc. | 01/17/2024SE |
| K232312 | GORE® PROPATEN® Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 01/09/2024SE |
| K233551 | GORE® ACUSEAL Vascular GraftDSY · Traditional | W. L. Gore & Associates, Inc. | 12/19/2023SE |
| K231505 | GORE® ACUSEAL Vascular GraftDSY · Special | W. L. Gore & Associates, Inc. | 06/23/2023SE |
More from W. L. Gore & Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922025 | Anastomart(Tm) Coronary Bypass Graft Markers/ModifDSY · Traditional | 09/22/1992SE |
| K905175 | Pti Annuloplasty Ring(Sterile)KRH · Traditional | 02/14/1992SE |
| K905068 | Pti Intra-Art (TM) Pick-Up WicksEFQ · Traditional | 12/31/1991SE |
| K910067 | Pti Sternal Closure Wire SutureGAQ · Traditional | 05/06/1991SE |
| K905067 | Pti Anastomark Flexible Coronary Bypass GraftDSY · Traditional | 03/18/1991SE |
| K901815 | Modified Sterilization of Intra-Art(Tm) CoronaryDRE · Traditional | 07/03/1990SE |
| K901531 | Pti Intra-Artr Reusable Coronary Artery ProbeDNP · Traditional | 06/20/1990SE |
| K901575 | Reusable TENS Paravertebral Pad #641 Back ElectrodGXY · Traditional | 05/02/1990SE |
| K897075 | Pti Intra-Art(Tm) Ansari Saphenous Vein HolderDXC · Traditional | 04/10/1990SE |
| K894684 | Pti Intra-Art Internal Mammary Artery Cannula KitDWF · Traditional | 10/17/1989SE |
Questions and answers
When was Pti Anastomark(Tm) Coronary Bypass Graft Markers cleared by the FDA?
Pti Anastomark(Tm) Coronary Bypass Graft Markers (K901682) received a 510(k) decision of Substantially Equivalent on July 3, 1990, 84 days after the submission was received.
What is the product code of K901682?
The FDA product code is DSY – Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, a Class II (moderate risk) device regulated under 21 CFR 870.3450.