K003535 is an FDA 510(k) clearance for the STYLET KIT, MODELS 6254,6282,6293. 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 February 8, 2001, 84 days after receiving the submission on November 16, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.
| 510(k) Number | K003535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2000 |
| Decision Date | February 08, 2001 |
| Days to Decision | 84 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 |