K233505 is an FDA 510(k) clearance for the Sapphire ULTRA Coronary Dilatation Catheter. This device is classified as a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II - Special Controls, product code LOX).
Submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 15, 2024, 289 days after receiving the submission on October 31, 2023.
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 | K233505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2023 |
| Decision Date | August 15, 2024 |
| Days to Decision | 289 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. |