K212393 is an FDA 510(k) clearance for the OPN NC PTCA Dilatation Catheter. This device is classified as a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II - Special Controls, product code LOX).
Submitted by Sis Medical AG (Frauenfeld, CH). The FDA issued a Cleared decision on March 14, 2022, 224 days after receiving the submission on August 2, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5100. A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End..
| 510(k) Number | K212393 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2021 |
| Decision Date | March 14, 2022 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LOX - Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5100 |
| Definition | A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End. |