Submission Details
| 510(k) Number | K063563 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 2006 |
| Decision Date | March 07, 2007 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER
Mar 2007
Decision
99d
Days
Class 2
Risk
About This 510(k) Submission
K063563 is an FDA 510(k) clearance for the CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis Europa, N.V. (Warren, US). The FDA issued a Cleared decision on March 7, 2007, 99 days after receiving the submission on November 28, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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