Submission Details
| 510(k) Number | K221986 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 06, 2022 |
| Decision Date | October 18, 2022 |
| Days to Decision | 104 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Oct 2022
Decision
104d
Days
Class 2
Risk
About This 510(k) Submission
K221986 is an FDA 510(k) clearance for the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter, a Catheter, Percutaneous, Cutting/scoring (Class II — Special Controls, product code PNO), submitted by Transit Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 18, 2022, 104 days after receiving the submission on July 6, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | PNO — Catheter, Percutaneous, Cutting/scoring |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material |
Manufacturer
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