PROSTHESIS, VASCULAR BIFURCATED
FDA 510(k) clearance K760130 · decided 1976-07-20
Clearance details
- K-number
- K760130
- Device name
- PROSTHESIS, VASCULAR BIFURCATED
- Applicant
- Usci, Div. C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-06-28
- Decision date
- 1976-07-20
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
|---|---|---|
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S006) | Usci, Div. C.R. Bard, Inc. | 1997-02-04 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S005) | Usci, Div. C.R. Bard, Inc. | 1996-11-26 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S004) | Usci, Div. C.R. Bard, Inc. | 1995-06-14 |
| USCI(R) PROBE III(TM) BALLOON-ON-A-WIRE(TM) D. SYS (P890048/S003) | Usci, Div. C.R. Bard, Inc. | 1995-05-17 |
| USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM (P890048) | Usci, Div. C.R. Bard, Inc. | 1991-04-17 |