K222538 is an FDA 510(k) clearance for the NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter. This device is classified as a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II - Special Controls, product code LOX).
Submitted by Sino Medical Sciences Technology, Inc. (Tianjin, CN). The FDA issued a Cleared decision on December 21, 2022, 121 days after receiving the submission on August 22, 2022.
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 | K222538 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2022 |
| Decision Date | December 21, 2022 |
| Days to Decision | 121 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. |