Submission Details
| 510(k) Number | K041061 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2004 |
| Decision Date | May 06, 2004 |
| Days to Decision | 13 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
May 2004
Decision
13d
Days
Class 2
Risk
About This 510(k) Submission
K041061 is an FDA 510(k) clearance for the D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC 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 May 6, 2004, 13 days after receiving the submission on April 23, 2004. 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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