THORATEC VAD SYSTEM
FDA premarket approval P870072/S046 · decided 2011-12-21
Approval details
- PMA number
- P870072
- Supplement
- S046
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THORATEC VAD SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Thoratec Laboratories Corp.
- Date received
- 2010-12-27
- Decision date
- 2011-12-21
- Days to decision
- 359 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT THORATEC CORPORATION IN SAN RAMON, CALIFORNIA FOR RECEIVING ACCEPTANCE ACTIVITIES, RECEIVING INSPECTION, WAREHOUSING, AND SHIPPING OPERATIONS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME (K001927) | Thoratec Laboratories Corp. | 2000-12-18 |
| VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES (K001926) | Thoratec Laboratories Corp. | 2000-09-22 |
| THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY (K851495) | Thoratec Laboratories Corp. | 1985-08-01 |
| RESPIRATORY ASSESSMENT SYSTEM (K833714) | Thoratec Laboratories Corp. | 1983-12-29 |
| RESPIRATORY FLOW MODULE (K833265) | Thoratec Laboratories Corp. | 1983-11-28 |
| INTRAOPERATIVE AUTOTRANSFUSION SYS (K831557) | Thoratec Laboratories Corp. | 1983-08-24 |
| RESPIRATORY GAS ANALYZER (K823449) | Thoratec Laboratories Corp. | 1983-01-05 |
| RESPIRATORY CIRCUIT ADAPTOR (K823287) | Thoratec Laboratories Corp. | 1982-12-09 |