Company
Medtronic Heart Valves Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (1 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Medtronic Heart Valves Division Medtronic Harmony Delivery Catheter System Open, Classified |
NPV | None listed |
| Jun 11, 2021 | Medtronic Heart Valves Division CoreValve Evolut PRO PLUS Delivery Catheter System,
REF:
D-EVPROP2329US;
D-EVPROP34US; Open, Classified |
NPT | None listed |
| Jun 11, 2021 | Medtronic Heart Valves Division CoreValve Evolut PRO Delivery Catheter System,
REF:
ENVPRO-14;
ENVPRO-16; Open, Classified |
NPT | None listed |
| Jun 11, 2021 | Medtronic Heart Valves Division CoreValve Evolut R Delivery Catheter System,
REF:
ENVEOR-L;
ENVEOR-N; Open, Classified |
NPT | None listed |
| Oct 23, 2020 | Medtronic Heart Valves Division Evolut (TM) PRO+ System. With the following model numbers:
a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US;
b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US Terminated |
NPT | None listed |
| Oct 23, 2020 | Medtronic Heart Valves Division Evolut (TM) PRO System. With the following model numbers:
a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EV Terminated |
NPT | None listed |
| Oct 23, 2020 | Medtronic Heart Valves Division Evolut (TM) R System. With the following model numbers:
a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLU Terminated |
NPT | None listed |