K083125 is an FDA 510(k) clearance for the NEURON SELECT CATHETER SIZE 070. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on November 21, 2008, 30 days after receiving the submission on October 22, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K083125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2008 |
| Decision Date | November 21, 2008 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |