K010906 is an FDA 510(k) clearance for the MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254. This device is classified as a Stylet, Catheter (Class II - Special Controls, product code DRB).
Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on April 5, 2001, 10 days after receiving the submission on March 26, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.
| 510(k) Number | K010906 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2001 |
| Decision Date | April 05, 2001 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRB — Stylet, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1380 |