K193607 is an FDA 510(k) clearance for the BOBBY Balloon Guide Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on July 21, 2020, 208 days after receiving the submission on December 26, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K193607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2019 |
| Decision Date | July 21, 2020 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |