Submission Details
| 510(k) Number | K232258 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 31, 2023 |
| Decision Date | June 17, 2024 |
| Days to Decision | 322 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
XO Constrain? Percutaneous Transluminal Angioplasty Constraining Catheter
Jun 2024
Decision
322d
Days
Class 2
Risk
About This 510(k) Submission
K232258 is an FDA 510(k) clearance for the XO Constrain? Percutaneous Transluminal Angioplasty Constraining 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 June 17, 2024, 322 days after receiving the submission on July 31, 2023. 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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