Submission Details
| 510(k) Number | K082873 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 29, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
Feb 2009
Decision
130d
Days
Class 2
Risk
About This 510(k) Submission
K082873 is an FDA 510(k) clearance for the MEDTRONIC ANGIOGRAPHIC GUIDE WIRES, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on February 6, 2009, 130 days after receiving the submission on September 29, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
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