Submission Details
| 510(k) Number | K050645 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2005 |
| Decision Date | April 01, 2005 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
CORDIS AMIIA .014 PTA BALLOON CATHETER
Apr 2005
Decision
18d
Days
Class 2
Risk
About This 510(k) Submission
K050645 is an FDA 510(k) clearance for the CORDIS AMIIA .014 PTA BALLOON CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on April 1, 2005, 18 days after receiving the submission on March 14, 2005. 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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