D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS— 510(k) K033987
Substantially EquivalentDideco S.P.A.
FDA 510(k) clearance K033987 for D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS, Substantially Equivalent on 2004-01-08. Applicant: Dideco S.P.A.. Device class: 2.
Clearance details
- Applicant
- Dideco S.P.A.
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Recent devices under product code DTM
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view all- K041061 — D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
- K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
- K033714 — MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
- K032040 — IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
- K031223 — SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.