Submission Details
| 510(k) Number | K091582 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 2009 |
| Decision Date | December 04, 2009 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
Dec 2009
Decision
185d
Days
Class 2
Risk
About This 510(k) Submission
K091582 is an FDA 510(k) clearance for the GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on December 4, 2009, 185 days after receiving the submission on June 2, 2009. 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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