DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER— 510(k) K040184
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K040184 for DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER, Substantially Equivalent on 2004-02-26. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- 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
- Arvada, CO, US
Recent devices under product code DTM
view allMore clearances from Cobe Cardiovascular, Inc.
view all- K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
- K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
- K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
- K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
- K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.