K161183 is an FDA 510(k) clearance for the Halo One Thin-Walled Guiding Sheath. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by C.R. Bard, Inc. (Enniscorthy, IE). The FDA issued a Cleared decision on June 3, 2016, 37 days after receiving the submission on April 27, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K161183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2016 |
| Decision Date | June 03, 2016 |
| Days to Decision | 37 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 |