BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK— 510(k) K013634

Unknown

Bioteque Corp.

FDA 510(k) clearance K013634 for BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK, Unknown on 2002-07-09. Applicant: Bioteque Corp..

Clearance details

Applicant: Bioteque Corp.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 2001-11-05
Decision date: 2002-07-09
Decision: Unknown
Clearance type: Traditional
Location: Flagstaff, AZ, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.