BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
FDA 510(k) clearance K933590 · decided 1994-01-26
Clearance details
- K-number
- K933590
- Device name
- BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1993-07-26
- Decision date
- 1994-01-26
- Days to decision
- 184 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fusion Bioline Vascular Graft (K252445) | Maquet Cardiovascular, LLC | 2026-04-27 |
| Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) | Vascular Flow Technologies Limited | 2025-10-20 |
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) | Atrium Medical Corporation | 2024-03-28 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |