COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET— 510(k) K974897
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K974897 for COBE BRAT 2 SYSTEM WITH MODIFIED STANDARD VOLUME PROCESSING SET, Substantially Equivalent on 1998-03-31. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code CAC
- Device class
- Class 2
- Regulation
- 21 CFR 868.5830
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvada, CO, US
Recent devices under product code CAC
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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 CAC
product code CAC- Death
- 11
- Malfunction
- 477
- Total
- 488
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.