Thoratec Laboratories Corp.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Thoratec Laboratories Corp.” (first 1978, latest 2000), plus 1 PMA decision, across 11 product codes in 2 review panels. Median 510(k) review time under this name: 68 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Abbott, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAC | Apparatus, Autotransfusion | 1 | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| DSQ | Ventricular (Assist) Bypass | 1 | 0 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
| JAX | Pneumotachometer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (5)
- Cardiovascular (5)
Most recent Thoratec Laboratories Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K001927 | VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME | DSY | 2000-12-18 | 175 |
| K001926 | VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES | DYB | 2000-09-22 | 88 |
| K851495 | THORATEC MULTILUMEN CENTRAL VENOUS CATH-TRAY | — | 1985-08-01 | 108 |
| K833714 | RESPIRATORY ASSESSMENT SYSTEM | BZL | 1983-12-29 | 69 |
| K833265 | RESPIRATORY FLOW MODULE | JAX | 1983-11-28 | 68 |
| K831557 | INTRAOPERATIVE AUTOTRANSFUSION SYS | CAC | 1983-08-24 | 100 |
| K823449 | RESPIRATORY GAS ANALYZER | CCL | 1983-01-05 | 54 |
| K823287 | RESPIRATORY CIRCUIT ADAPTOR | BZO | 1982-12-09 | 35 |
| K822769 | THORATEC GAS SAMPLING CONNECTOR | CAI | 1982-10-06 | 22 |
| K780247 | IMPCO DISPOSABLE AORTIC PUNCH | DWS | 1978-02-27 | 14 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P870072 | PMA | THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM | 1995-12-20 |
Recalls
openFDA lists no recalls under a recalling firm named Thoratec Laboratories Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Thoratec Corporation (3 510(k)s)
- Thoratec Corporation (Now Part of Abbott) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thoratec Laboratories Corp.?
FDA lists 10 510(k) clearances under the applicant name “Thoratec Laboratories Corp.” (first 1978, latest 2000), plus 1 PMA decision, across 11 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thoratec Laboratories Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thoratec Laboratories Corp. is 68 days.
Which FDA product codes appear under Thoratec Laboratories Corp.?
The most frequent FDA product codes under this applicant name are BZL (Computer, Oxygen-Uptake, 1); BZO (Set, Tubing And Support, Ventilator (W Harness), 1); CAC (Apparatus, Autotransfusion, 1).
Next steps
- See all 10 Thoratec Laboratories Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZL, Thoratec Laboratories Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.