K221951 is an FDA 510(k) clearance for the Branchor Balloon Guide Catheter. This device is classified as a Catheter, Percutaneous, Neurovasculature (Class II - Special Controls, product code QJP).
Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on October 11, 2022, 98 days after receiving the submission on July 5, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250. To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures.
| 510(k) Number | K221951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2022 |
| Decision Date | October 11, 2022 |
| Days to Decision | 98 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | QJP — Catheter, Percutaneous, Neurovasculature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures |