K202916 is an FDA 510(k) clearance for the Balloon Guiding Catheter. This device is classified as a Catheter, Percutaneous, Neurovasculature (Class II - Special Controls, product code QJP).
Submitted by Shanghai Heartcare Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on August 25, 2021, 330 days after receiving the submission on September 29, 2020.
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 | K202916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2020 |
| Decision Date | August 25, 2021 |
| Days to Decision | 330 days |
| Submission Type | Traditional |
| 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 |