K201271 is an FDA 510(k) clearance for the Benchmark BMX96 Access System. 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 June 11, 2020, 30 days after receiving the submission on May 12, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K201271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2020 |
| Decision Date | June 11, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |