Thoratec Corporation: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Thoratec Corporation” (first 2013, latest 2015), plus 1 PMA decision, across 3 product codes in 1 review panel. Median 510(k) review time under this name: 46 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 |
|---|---|---|
| 2013 | 1 | 84 |
| 2014 | 0 | — |
| 2015 | 2 | 45 |
| 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| DSQ | Ventricular (Assist) Bypass | 1 | 0 |
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (4)
Most recent Thoratec Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152190 | Thoratec CentriMag Drainage (Venous) Cannula Kit | DWF | 2015-09-18 | 44 |
| K152161 | Thoratec CentriMag Return (Arterial) Cannula Kit | DWF | 2015-09-18 | 46 |
| K131179 | CENTRIMAG PRIMARY CONSOLE (2ND GENERATION); MAG MONITOR | DWA | 2013-07-18 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P920014 | PMA | HEARTMATE VE LVAS | 1994-09-30 |
Recalls
43 product recalls in 29 recall events; 20 initiated in the last five years. Most recent: 2026-05-13.
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 Laboratories Corp. (10 510(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 Corporation?
FDA lists 3 510(k) clearances under the applicant name “Thoratec Corporation” (first 2013, latest 2015), plus 1 PMA decision, across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Thoratec Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thoratec Corporation is 46 days.
Which FDA product codes appear under Thoratec Corporation?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 2); DSQ (Ventricular (Assist) Bypass, 1); DWA (Control, Pump Speed, Cardiopulmonary Bypass, 1).
Next steps
- See all 3 Thoratec Corporation clearances with predicates and recalls
- Run predicate analysis for product code DWF, Thoratec Corporation'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.