TORAY VASCULAR PROSTHESIS
FDA 510(k) clearance K884083 · decided 1989-01-12
Clearance details
- K-number
- K884083
- Device name
- TORAY VASCULAR PROSTHESIS
- Applicant
- Toray Industries (America), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-27
- Decision date
- 1989-01-12
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Toray Industries (America)
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 |
|---|---|---|
| INOUE BALLOON CATHETER (P910054/S010) | Toray Industries (America), Inc. | 2024-07-01 |
| Inoue-Balloon Catheter (P910054/S009) | Toray Industries (America), Inc. | 2024-05-24 |
| INOUE-BALLOON Catheter (P910054/S008) | Toray Industries (America), Inc. | 2021-08-31 |
| Inoue Balloon Catheter (P910054/S007) | Toray Industries (America), Inc. | 2020-03-30 |
| Toray Inoue Balloon Catheter (P910054/S006) | Toray Industries (America), Inc. | 2018-09-13 |
| TORAY INOUE BALLOON CATHETER (P910054/S005) | Toray Industries (America), Inc. | 2011-05-17 |
| TORAY INOUE BALLON CATHETER (P910054/S004) | Toray Industries (America), Inc. | 2007-07-03 |
| INOUE BALLOON CATHETER (P910054/S002) | Toray Industries (America), Inc. | 2002-02-13 |