Submission Details
| 510(k) Number | K083422 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 19, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 79 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
6F TAIGA GUIDING CATHETER
Feb 2009
Decision
79d
Days
Class 2
Risk
About This 510(k) Submission
K083422 is an FDA 510(k) clearance for the 6F TAIGA GUIDING CATHETER, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic Vascular (Danvers, US). The FDA issued a Cleared decision on February 6, 2009, 79 days after receiving the submission on November 19, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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