K180921 is an FDA 510(k) clearance for the Sapphire II PRO Balloon Dilatation Catheter. This device is classified as a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II - Special Controls, product code LOX).
Submitted by Orbusneich Medical Trading, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on June 28, 2018, 80 days after receiving the submission on April 9, 2018.
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 | K180921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2018 |
| Decision Date | June 28, 2018 |
| Days to Decision | 80 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. |