K070970 is an FDA 510(k) clearance for the NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Penumbra, Inc. (San Leandro, US). The FDA issued a Cleared decision on August 17, 2007, 133 days after receiving the submission on April 6, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K070970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2007 |
| Decision Date | August 17, 2007 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |