Submission Details
| 510(k) Number | K062420 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 2006 |
| Decision Date | September 08, 2006 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
5F SHERPA ACTIVE NX GUIDE CATHETER
Sep 2006
Decision
21d
Days
Class 2
Risk
About This 510(k) Submission
K062420 is an FDA 510(k) clearance for the 5F SHERPA ACTIVE NX 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 September 8, 2006, 21 days after receiving the submission on August 18, 2006. 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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