BT CATH (INTRAVASCULAR CATHETER)— 510(k) K862480

Name: FDA 510(k) clearance K862480
Creator: U.S. Food and Drug Administration
Published: 1986-07-31

Substantially Equivalent

Baron Technologies, Inc.

FDA 510(k) clearance K862480 for BT CATH (INTRAVASCULAR CATHETER), Substantially Equivalent on 1986-07-31. Applicant: Baron Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Baron Technologies, Inc.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1986-06-30
Decision date: 1986-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K864541 — BT HYPODERMIC SYRINGE1987-01-21

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.