Medtronic Cardiac Surgical Products: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Medtronic Cardiac Surgical Products” (first 2000, latest 2003), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 106 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 Medtronic, 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 6 | 6 |
| DRA | Catheter, Steerable | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Medtronic Cardiac Surgical Products 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) | DWF | 2003-01-08 | 177 |
| K013013 | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. | DWF | 2001-12-04 | 88 |
| K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 | DRA | 2001-10-24 | 106 |
| K010737 | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 | DWF | 2001-04-04 | 23 |
| K000776 | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP | DWF | 2001-02-07 | 334 |
| K994171 | MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE | DWF | 2000-04-27 | 139 |
| K000274 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE | DWF | 2000-02-10 | 10 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Cardiac Surgical Products.
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.
- Medtronic Vascular (480 510(k)s)
- Medtronic Sofamor Danek (253 510(k)s)
- Medtronic, Inc. (247 510(k)s)
- Medtronic Sofamor Danek USA, Inc. (182 510(k)s)
- Medtronic Minimed (57 510(k)s)
- Medtronic Xomed, Inc. (47 510(k)s)
- Medtronic Navigation, Inc. (44 510(k)s)
- Medtronic Perfusion Systems (29 510(k)s)
- Medtronic Neurosurgery (27 510(k)s)
- Medtronic Blood Systems, Inc. (15 510(k)s)
- Medtronic PS Medical (14 510(k)s)
- Medtronic Ave, Inc. (13 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medtronic Cardiac Surgical Products?
FDA lists 7 510(k) clearances under the applicant name “Medtronic Cardiac Surgical Products” (first 2000, latest 2003), across 2 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 Medtronic Cardiac Surgical Products?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Cardiac Surgical Products is 106 days.
Which FDA product codes appear under Medtronic Cardiac Surgical Products?
The most frequent FDA product codes under this applicant name are DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 6); DRA (Catheter, Steerable, 1).
Next steps
- See all 7 Medtronic Cardiac Surgical Products clearances with predicates and recalls
- Run predicate analysis for product code DWF, Medtronic Cardiac Surgical Products'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.