510(k) Report

FDA applicant

Catheter Technology Corp.

Walker, MI13 decisions1983–19883 recalls

FDA records 13 decisions for Catheter Technology Corp. (Walker, MI) from 1983 to 1988: 13 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and JHJ (Agglutination Method, Human Chorionic…). 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Catheter Technology Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Catheter Technology Corp. since 2007.

Recalls per year

1in 2023

2014: 12019: 12023: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Catheter Technology Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Catheter”

FDA records each applicant name separately; these may or may not be the same firm.