Concerto Versa Detachable Coil— 510(k) K261866
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K261866 for Concerto Versa Detachable Coil, Substantially Equivalent on 2026-06-24. Applicant: Medtronic, Inc.. Device class: 2.
Summary
Medtronic's Concerto Versa Detachable Coil is filed under KRD, vascular devices for promoting embolization. The record gives no coil sizes or model numbers.
Class II, 21 CFR 870.3300. Cardiovascular is both the classification panel and the review panel. It was a Special 510(k).
Medtronic filed from Plymouth, Minnesota. Review took 20 calendar days (June 4 to June 24, 2026).
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Product code KRD
- Device class
- Class 2
- Regulation
- 21 CFR 870.3300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
Recent devices under product code KRD
view allMore clearances from Medtronic, Inc.
view allAdverse events under product code KRD
product code KRD- Death
- 119
- Injury
- 1,869
- Malfunction
- 7,015
- Other
- 1
- Total
- 9,004
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.