The following data is part of a premarket notification filed by Transit Scientific with the FDA for Xo Score Percutaneous Transluminal Angioplasty Scoring Catheter.
| Device ID | K193495 |
| 510k Number | K193495 |
| Device Name: | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter |
| Classification | Catheter, Percutaneous, Cutting/scoring |
| Applicant | Transit Scientific 2757 South 300 West, Suite E Salt Lake City, UT 84115 |
| Contact | Jenifer Arnold |
| Correspondent | Srividya Pothana University Of Utah 10 North 1900 East, EHSL Rm. 22B Salt Lake City, UT 84112 |
| Product Code | PNO |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-05-29 |