Submission Details
| 510(k) Number | K222873 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 22, 2022 |
| Decision Date | November 07, 2022 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
Nov 2022
Decision
46d
Days
Class 2
Risk
About This 510(k) Submission
K222873 is an FDA 510(k) clearance for the Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on November 7, 2022, 46 days after receiving the submission on September 22, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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