Submission Details
| 510(k) Number | K210322 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2021 |
| Decision Date | October 21, 2021 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
XO Cross Support Catheter
Oct 2021
Decision
259d
Days
Class 2
Risk
About This 510(k) Submission
K210322 is an FDA 510(k) clearance for the XO Cross 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 October 21, 2021, 259 days after receiving the submission on February 4, 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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