Thoratec Laboratories Corp.
Pleasanton, CA, US
Thoratec Laboratories Corp. appears in FDA device records in Pleasanton, CA. FDA records list 10 510(k) clearances between and , 59 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 10
- PMA records
- 59
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 10 510(k) clearances for Thoratec Laboratories Corp. between 1978 and 2000. The busiest year on record is 1983, with 4. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1982 | 2 |
| 1983 | 4 |
| 1985 | 1 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME | DSY | Substantially Equivalent | |
| K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES | DYB | Substantially Equivalent | |
| K851495 | THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY | Unknown | ||
| K833714 | RESPIRATORY ASSESSMENT SYSTEM | BZL | Substantially Equivalent | |
| K833265 | RESPIRATORY FLOW MODULE | JAX | Substantially Equivalent | |
| K831557 | INTRAOPERATIVE AUTOTRANSFUSION SYS | CAC | Substantially Equivalent | |
| K823449 | RESPIRATORY GAS ANALYZER | CCL | Substantially Equivalent | |
| K823287 | RESPIRATORY CIRCUIT ADAPTOR | BZO | Substantially Equivalent | |
| K822769 | THORATEC GAS SAMPLING CONNECTOR | CAI | Substantially Equivalent | |
| K780247 | IMPCO DISPOSABLE AORTIC PUNCH | DWS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CACApparatus, Autotransfusion
- CAICircuit, Breathing (W Connector, Adaptor, Y Piece)
- BZLComputer, Oxygen-Uptake
- DWSInstruments, Surgical, Cardiovascular
- DYBIntroducer, Catheter
- JAXPneumotachometer
- DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter
- BZOSet, Tubing And Support, Ventilator (W Harness)
- DSQVentricular (Assist) Bypass
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain