K000955 is an FDA 510(k) clearance for the PLACER MODEL 6232 STEERABLE STYLET. This device is classified as a Stylet, Catheter (Class II - Special Controls, product code DRB).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on June 16, 2000, 84 days after receiving the submission on March 24, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1380.
| 510(k) Number | K000955 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2000 |
| Decision Date | June 16, 2000 |
| 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 |