20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System— 510(k) K160374

Name: FDA 510(k) clearance K160374
Creator: U.S. Food and Drug Administration
Published: 2016-03-11

Substantially Equivalent

Tangent Medical Technologies, Inc.

FDA 510(k) clearance K160374 for 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System, Substantially Equivalent on 2016-03-11. Applicant: Tangent Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Tangent Medical Technologies, Inc.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 2016-02-10
Decision date: 2016-03-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOZ

view all

K260432 — Ruby Intravascular Catheter2026-09-02
K260165 — Unimpregnated Central Venous Catheter2026-08-10
K261041 — ClearSafe Closed System2026-07-10
K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

More clearances from Tangent Medical Technologies, Inc.

view all

K120839 — NOVACATH SECURE IV CATHETER SYSTEM-18G2012-07-20

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.