Submission Details
| 510(k) Number | K133539 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2013 |
| Decision Date | March 26, 2014 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
TOTAL ACROSS
Mar 2014
Decision
128d
Days
Class 2
Risk
About This 510(k) Submission
K133539 is an FDA 510(k) clearance for the TOTAL ACROSS, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on March 26, 2014, 128 days after receiving the submission on November 18, 2013. 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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