Submission Details
| 510(k) Number | K112735 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2011 |
| Decision Date | November 02, 2012 |
| Days to Decision | 409 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
TAMARIN BLUE PTCA RX DILATATION CATHETER
Nov 2012
Decision
409d
Days
Class 2
Risk
About This 510(k) Submission
K112735 is an FDA 510(k) clearance for the TAMARIN BLUE PTCA RX DILATATION CATHETER, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Natec Medical , Ltd. (Crofton, US). The FDA issued a Cleared decision on November 2, 2012, 409 days after receiving the submission on September 20, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.
Device Classification
| 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. |
Manufacturer
Similar Devices — LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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