The following data is part of a premarket notification filed by Transit Scientific, Llc with the FDA for Xo Cross Support Catheter.
| Device ID | K210322 |
| 510k Number | K210322 |
| Device Name: | XO Cross Support Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Transit Scientific, LLC 2757 South 300 West, Suite E Salt Lake City, UT 84115 |
| Contact | Jenifer Arnold |
| Correspondent | Spencer Walker University Of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, UT 84112 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-04 |
| Decision Date | 2021-10-21 |