K121196 is an FDA 510(k) clearance for the EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE). This device is classified as a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II - Special Controls, product code LOX).
Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on August 31, 2012, 134 days after receiving the submission on April 19, 2012.
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 | K121196 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 2012 |
| Decision Date | August 31, 2012 |
| Days to Decision | 134 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. |