COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT— 510(k) K853100

Name: FDA 510(k) clearance K853100
Creator: U.S. Food and Drug Administration
Published: 1985-09-25

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K853100 for COBE CATHETER W/GUIDEWIRE ASSEMBLY KIT, Substantially Equivalent on 1985-09-25. Applicant: Cobe Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1985-07-23
Decision date: 1985-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.