TELET-LEX MEDICAL IV CATHETER PLACEMENT— 510(k) K851142

Substantially Equivalent

Teleflexmedical, Inc.

FDA 510(k) clearance K851142 for TELET-LEX MEDICAL IV CATHETER PLACEMENT, Substantially Equivalent on 1985-07-05. Applicant: Teleflexmedical, Inc..

Clearance details

Applicant: Teleflexmedical, Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1985-03-21
Decision date: 1985-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffrey, NH, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.