Medtronic Cardiac Surgery: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Medtronic Cardiac Surgery” (first 2024, latest 2024), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 28 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 |
|---|---|---|
| 2024 | 1 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medtronic Cardiac Surgery took a median 28 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 1 | 1 |
| LWQ | Heart-Valve, Mechanical | 1 | 0 |
Review panels
- Cardiovascular (2)
Most recent Medtronic Cardiac Surgery 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 800 mL; MVR Venous Reservoir Bag with Cortiva BioActive Surface 1600 mL | DTN | 2024-05-15 | 28 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P790018 | PMA | MEDTRONIC(R) HALL PROSTHETIC HEART VALVE | 1981-12-23 |
Recalls
openFDA lists no recalls under a recalling firm named Medtronic Cardiac Surgery.
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.
Device clinical trials
An industry sponsor named Medtronic Cardiac Surgery is the lead sponsor of 9 device studies on ClinicalTrials.gov (5 active or recruiting). Most recent:
- NCT06506903: Avalus Ultra Post-Approval Study (PAS) (Active not recruiting, started 2024-11-20)
- NCT06203054: CLIP-IT Post-Market Study (Active not recruiting, started 2024-02-26)
- NCT04073420: Medtronic Cardiac Surgery PMCF Registry (Recruiting, started 2019-12-02)
- NCT03546374: Medtronic Terminate AF Study (Recruiting, started 2018-11-15)
- NCT03139721: Medtronic HAMMOCK Post Approval Study (Completed, started 2017-06-19)
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 Surgery?
FDA lists 1 510(k) clearance under the applicant name “Medtronic Cardiac Surgery” (first 2024, latest 2024), plus 1 PMA decision, 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 Surgery?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medtronic Cardiac Surgery is 28 days.
Which FDA product codes appear under Medtronic Cardiac Surgery?
The most frequent FDA product codes under this applicant name are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 1); LWQ (Heart-Valve, Mechanical, 1).
Next steps
- See all 1 Medtronic Cardiac Surgery clearances with predicates and recalls
- Run predicate analysis for product code DTN, Medtronic Cardiac Surgery'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.