COBE CENTURY PERFUSION PUMP— 510(k) K960974
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K960974 for COBE CENTURY PERFUSION PUMP, Substantially Equivalent on 1997-07-14. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code DWB
- Device class
- Class 2
- Regulation
- 21 CFR 870.4370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvada, CO, US
Recent devices under product code DWB
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- K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM
- K972321 — S3 MAST PUMP
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
- K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
Adverse events under product code DWB
product code DWB- Death
- 2
- Total
- 2
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.