Company ยท US
Thoratec Laboratories Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2000. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZL | Computer, Oxygen-Uptake | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 |
| CAC | Apparatus, Autotransfusion | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 |
| DYB | Introducer, Catheter | 1 |
| JAX | Pneumotachometer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2000 | K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME Thoratec Laboratories Corp. | DSY |
| Sep 22, 2000 | K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES Thoratec Laboratories Corp. | DYB |
| Aug 1, 1985 | K851495 | THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY Thoratec Laboratories Corp. | |
| Dec 29, 1983 | K833714 | RESPIRATORY ASSESSMENT SYSTEM Thoratec Laboratories Corp. | BZL |
| Nov 28, 1983 | K833265 | RESPIRATORY FLOW MODULE Thoratec Laboratories Corp. | JAX |
| Aug 24, 1983 | K831557 | INTRAOPERATIVE AUTOTRANSFUSION SYS Thoratec Laboratories Corp. | CAC |
| Jan 5, 1983 | K823449 | RESPIRATORY GAS ANALYZER Thoratec Laboratories Corp. | CCL |
| Dec 9, 1982 | K823287 | RESPIRATORY CIRCUIT ADAPTOR Thoratec Laboratories Corp. | BZO |
| Oct 6, 1982 | K822769 | THORATEC GAS SAMPLING CONNECTOR Thoratec Laboratories Corp. | CAI |
| Feb 27, 1978 | K780247 | IMPCO DISPOSABLE AORTIC PUNCH Thoratec Laboratories Corp. | DWS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||