I.V. START KIT— 510(k) K931729

Name: FDA 510(k) clearance K931729
Creator: U.S. Food and Drug Administration
Published: 1994-02-22

Unknown

Carapace, Inc.

FDA 510(k) clearance K931729 for I.V. START KIT, Unknown on 1994-02-22. Applicant: Carapace, Inc.. Device class: 2.

Clearance details

Applicant: Carapace, Inc.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1993-04-07
Decision date: 1994-02-22
Decision: Unknown
Clearance type: Traditional
Location: Broken Arrow, OK, US

Download summary PDF View on FDA.gov ↗

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More clearances from Carapace, Inc.

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K931722 — CARAPACE LABOR AND DELIVERY SETS1994-03-23
K931822 — CARAPACE PELVIC EXAM TRAYS1994-03-07
K931669 — CARAPACE DEBRIDEMENT KITS1994-02-07
K931820 — CARAPACE STILLWATER BOWL SET1994-02-07
K931760 — CARAPACE PACKING GAUZE TRAYS1994-02-04

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.