The Heart Valve Div. Medtronic Cardiovascular Surg: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “The Heart Valve Div. Medtronic Cardiovascular Surg” (first 1991, latest 1998), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 193 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| KRH | Ring, Annuloplasty | 3 | 3 |
| LDF | Electrode, Pacemaker, Temporary | 2 | 2 |
Review panels
- Cardiovascular (5)
Most recent The Heart Valve Div. Medtronic Cardiovascular Surg 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980534 | DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H | KRH | 1998-04-30 | 78 |
| K960356 | POSTERIOR ANNULOPLASTY BAND (MODEL 607) | KRH | 1996-08-27 | 215 |
| K944956 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 | LDF | 1995-07-14 | 280 |
| K922269 | UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 | LDF | 1992-11-23 | 193 |
| K914602 | DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED | KRH | 1991-11-22 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named The Heart Valve Div. Medtronic Cardiovascular Surg.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Heart Valve Div. Medtronic Cardiovascular Surg?
FDA lists 5 510(k) clearances under the applicant name “The Heart Valve Div. Medtronic Cardiovascular Surg” (first 1991, latest 1998), 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 The Heart Valve Div. Medtronic Cardiovascular Surg?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Heart Valve Div. Medtronic Cardiovascular Surg is 193 days.
Which FDA product codes appear under The Heart Valve Div. Medtronic Cardiovascular Surg?
The most frequent FDA product codes under this applicant name are KRH (Ring, Annuloplasty, 3); LDF (Electrode, Pacemaker, Temporary, 2).
Next steps
- See all 5 The Heart Valve Div. Medtronic Cardiovascular Surg clearances with predicates and recalls
- Run predicate analysis for product code KRH, The Heart Valve Div. Medtronic Cardiovascular Surg'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.