Submission Details
| 510(k) Number | K232190 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 2023 |
| Decision Date | August 22, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
Aug 2023
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K232190 is an FDA 510(k) clearance for the 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on August 22, 2023, 29 days after receiving the submission on July 24, 2023. 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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