K082847 is an FDA 510(k) clearance for the PINNACLE ROII INTRODUCER 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 October 29, 2008, 30 days after receiving the submission on September 29, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K082847 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2008 |
| Decision Date | October 29, 2008 |
| Days to Decision | 30 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 |