COMCASET SAFETY IV CATHETER— 510(k) K062108

Name: FDA 510(k) clearance K062108
Creator: U.S. Food and Drug Administration
Published: 2006-08-08

Substantially Equivalent

Pitango Medical, Ltd.

FDA 510(k) clearance K062108 for COMCASET SAFETY IV CATHETER, Substantially Equivalent on 2006-08-08. Applicant: Pitango Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Pitango Medical, Ltd.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2006-07-24
Decision date: 2006-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Gan, IL

Download summary PDF View on FDA.gov ↗

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K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

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K070020 — COMCASET-P SAFETY IV CATHETER2007-08-16

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.