ERYPUR B— 510(k) K864636

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K864636 for ERYPUR B, Substantially Equivalent on 1987-01-14. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1986-11-26
Decision date: 1987-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kensington, TX, US

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Adverse events under product code CAK

product code CAK

Malfunction: 476
Total: 476

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.