K170997 is an FDA 510(k) clearance for the CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Biosense Webster, Inc. (Irvin, US). The FDA issued a Cleared decision on July 25, 2017, 113 days after receiving the submission on April 3, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K170997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2017 |
| Decision Date | July 25, 2017 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB — Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |