Baxter Eptfe Externally Supported Vascular Grafts
FDA 510(k) K944858 · Baxter Edwards
510(k) numberK944858
Submission
- Device name
- Baxter Eptfe Externally Supported Vascular Grafts
- Applicant
- Baxter Edwards
Irvine, CA, US - Received
- October 3, 1994
- Decision date
- January 5, 1995
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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 |
|---|---|---|
| K993816 | Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and PMT1206FDMCW · Traditional | 05/04/2000SE |
| K981909 | Baxter Hemostasis Valve IntroducersDYB · Traditional | 11/24/1998SE |
| K980487 | Carpenter-Edwards Classic Ring with Duraflo Treatment Models 4425 (Mitral) and 4525…KRH · Traditional | 07/07/1998SE |
| K965137 | Fogarty Valvulotome Model 700091MGZ · Traditional | 06/04/1997SE |
| K964021 | Intramed Side Branch Occlusion (Sbo) System (700095 and 700099)HCG · Traditional | 03/27/1997SE |
| K955839 | Multi-Med Multi-Lumen Central Venous CatheterFOZ · Traditional | 03/25/1996SE |
| K952638 | 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to AS the…LYK · Traditional | 07/28/1995SE |
| K944214 | Baxter Handle Model 1150DTJ · Traditional | 02/10/1995SE |
| K940795 | Swan-Ganz CC0/SVO2 Thermodilution CatheterDYG · Traditional | 05/24/1994SE |
| K926433 | 4.5F Imagecath(R) Coronary Angioscope, COV45LYK · Traditional | 03/23/1993SE |
Questions and answers
When was Baxter Eptfe Externally Supported Vascular Grafts cleared by the FDA?
Baxter Eptfe Externally Supported Vascular Grafts (K944858) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on January 5, 1995, 94 days after the submission was received.
What is the product code of K944858?
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.