16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR— 510(k) K885202

Name: FDA 510(k) clearance K885202
Creator: U.S. Food and Drug Administration
Published: 1989-01-31

Substantially Equivalent

Coeur Laboratories, Inc.

FDA 510(k) clearance K885202 for 16 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR, Substantially Equivalent on 1989-01-31. Applicant: Coeur Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Coeur Laboratories, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1988-12-16
Decision date: 1989-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raleigh, NC, US

Download summary PDF View on FDA.gov ↗

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K890292 — PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE1989-06-22
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Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.