Submission Details
| 510(k) Number | K033987 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 23, 2003 |
| Decision Date | January 08, 2004 |
| Days to Decision | 16 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
Jan 2004
Decision
16d
Days
Class 2
Risk
About This 510(k) Submission
K033987 is an FDA 510(k) clearance for the D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on January 8, 2004, 16 days after receiving the submission on December 23, 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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