Submission Details
| 510(k) Number | K040173 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 2004 |
| Decision Date | March 19, 2004 |
| Days to Decision | 53 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
PEDIATRIC AORTIC ROOT CANNULA
Mar 2004
Decision
53d
Days
Class 2
Risk
About This 510(k) Submission
K040173 is an FDA 510(k) clearance for the PEDIATRIC AORTIC ROOT CANNULA, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on March 19, 2004, 53 days after receiving the submission on January 26, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Manufacturer
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