COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700— 510(k) K030462
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K030462 for COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700, Substantially Equivalent on 2003-03-06. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code KFM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4360
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Arvada, CO, US
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More clearances from Cobe Cardiovascular, Inc.
view all- K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
- K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
- K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
- K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
- K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
Adverse events under product code KFM
product code KFM- Death
- 109
- Injury
- 241
- Malfunction
- 1,779
- Total
- 2,129
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.