Submission Details
| 510(k) Number | K214107 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 29, 2021 |
| Decision Date | April 11, 2022 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
XO CROSS CORONARY Support Catheter
Apr 2022
Decision
103d
Days
Class 2
Risk
About This 510(k) Submission
K214107 is an FDA 510(k) clearance for the XO CROSS CORONARY Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Transit Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on April 11, 2022, 103 days after receiving the submission on December 29, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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