Submission Details
| 510(k) Number | K071189 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 30, 2007 |
| Decision Date | May 16, 2007 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
K071189 - CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
(FDA 510(k) Clearance)
May 2007
Decision
16d
Days
Class 2
Risk
K071189 is an FDA 510(k) clearance for the CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis Europa, N.V. (Roden, Drenthe, NL). The FDA issued a Cleared decision on May 16, 2007, 16 days after receiving the submission on April 30, 2007. 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 |
Similar Devices — LIT Catheter, Angioplasty, Peripheral, Transluminal
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