VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
FDA 510(k) clearance K001927 · decided 2000-12-18
Clearance details
- K-number
- K001927
- Device name
- VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
- Applicant
- Thoratec Laboratories Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-06-26
- Decision date
- 2000-12-18
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM (P870072/S062) | Thoratec Laboratories Corp. | 2016-06-14 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S061) | Thoratec Laboratories Corp. | 2016-01-21 |
| THORATEC VENTRICULAR ASSIST DEVICE SYSTEM (P870072/S060) | Thoratec Laboratories Corp. | 2015-06-04 |
| THORATEC VENTRICULAR ASSIST DEVICE (P870072/S059) | Thoratec Laboratories Corp. | 2014-03-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S058) | Thoratec Laboratories Corp. | 2013-12-19 |
| THORATEC VENTRICULAR ASSIST DEVICE(VAD) (P870072/S057) | Thoratec Laboratories Corp. | 2013-12-18 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S055) | Thoratec Laboratories Corp. | 2013-12-10 |
| THORATEC VENTRICULAR ASSIST DEVICE (VAD) (P870072/S054) | Thoratec Laboratories Corp. | 2013-10-11 |