ATRIUM'S HYBRID PTFE
FDA 510(k) clearance K933391 · decided 1994-12-15
Clearance details
- K-number
- K933391
- Device name
- ATRIUM'S HYBRID PTFE
- Applicant
- Atrium Medical Corp.
- Decision
- Unknown
- Date received
- 1993-07-12
- Decision date
- 1994-12-15
- Days to decision
- 521 days
- Clearance type
- Traditional
- Product code
- DYF
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hollis, NH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (K004012) | Impra, Inc. | 2001-05-14 |
| ADVANTA SUPER SOFT GRAFT (K000504) | Atrium Medical Corp. | 2000-03-01 |
| ADVANTA GRAFT (<6MM) (K992958) | Atrium Medical Corp. | 1999-10-01 |
| PTFE RINGED GORE-TEX VASCULAR GRAFT (K991683) | W. L. Gore & Associates, Inc. | 1999-09-08 |
| ADVANTA GRAFT (K992441) | Atrium Medical Corp. | 1999-08-20 |
| PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (K984183) | Possis Medical, Inc. | 1999-02-01 |
| DISTAFLO BYPASS GRAFT (K983769) | Impra, Inc. | 1998-12-15 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981076) | Impra, Inc. | 1998-05-07 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K964877) | Impra, Inc. | 1997-03-20 |
| MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (K960766) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 |
| DIASTAT VASCULAR ACCESS GRAFT (K955533) | W. L. Gore & Associates, Inc. | 1996-05-15 |
| DIASTAT VASCULAR ACCESS GRAFT (K953287) | W. L. Gore & Associates, Inc. | 1995-10-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| iCast Covered Stent System (P120003/S009) | Atrium Medical Corp. | 2025-12-22 |
| iCast Covered Stent System (P120003/S011) | Atrium Medical Corp. | 2025-09-12 |
| iCast Covered Stent System (P120003/S010) | Atrium Medical Corp. | 2025-08-20 |
| iCast Covered Stent System (P120003/S006) | Atrium Medical Corp. | 2025-07-07 |
| iCast Covered Stent System (P120003/S008) | Atrium Medical Corp. | 2025-05-01 |
| iCast Covered Stent System (P120003/S005) | Atrium Medical Corp. | 2024-08-07 |
| iCast Covered Stent System (P120003/S004) | Atrium Medical Corp. | 2024-07-24 |
| iCast Covered Stent System (P120003/S003) | Atrium Medical Corp. | 2023-10-18 |