Submission Details
| 510(k) Number | K043179 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2004 |
| Decision Date | February 08, 2005 |
| Days to Decision | 83 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
SELECT 3D ARTERIAL CANNULA
Feb 2005
Decision
83d
Days
Class 2
Risk
About This 510(k) Submission
K043179 is an FDA 510(k) clearance for the SELECT 3D ARTERIAL 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 February 8, 2005, 83 days after receiving the submission on November 17, 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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