K203764 is an FDA 510(k) clearance for the TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform. This device is classified as a Catheter, Percutaneous, Neurovasculature (Class II - Special Controls, product code QJP).
Submitted by Imperative Care, Inc. (Campbell, US). The FDA issued a Cleared decision on March 3, 2021, 70 days after receiving the submission on December 23, 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 | K203764 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2020 |
| Decision Date | March 03, 2021 |
| Days to Decision | 70 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 |