Submission Details
| 510(k) Number | K033468 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 03, 2003 |
| Decision Date | November 14, 2003 |
| Days to Decision | 11 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
Nov 2003
Decision
11d
Days
Class 2
Risk
About This 510(k) Submission
K033468 is an FDA 510(k) clearance for the AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on November 14, 2003, 11 days after receiving the submission on November 3, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.
Device Classification
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4260 |
Manufacturer
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