Submission Details
| 510(k) Number | K081573 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 2008 |
| Decision Date | June 27, 2008 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MEDTRONIC EXPORT AP CATHETER
Jun 2008
Decision
22d
Days
Class 2
Risk
About This 510(k) Submission
K081573 is an FDA 510(k) clearance for the MEDTRONIC EXPORT AP CATHETER, a Catheter, Embolectomy (Class II — Special Controls, product code DXE), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on June 27, 2008, 22 days after receiving the submission on June 5, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
Device Classification
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
Manufacturer
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