K091329 is an FDA 510(k) clearance for the PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on May 29, 2009, 24 days after receiving the submission on May 5, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K091329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2009 |
| Decision Date | May 29, 2009 |
| Days to Decision | 24 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |