ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC)— 510(k) K944511

Name: FDA 510(k) clearance K944511
Creator: U.S. Food and Drug Administration
Published: 1995-03-13

Substantially Equivalent

Neostar Medical Technologies, Inc.

FDA 510(k) clearance K944511 for ACUTE CENTRAL VENOUS ACCESS CATHETER (ACVAC), Substantially Equivalent on 1995-03-13. Applicant: Neostar Medical Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Neostar Medical Technologies, Inc.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1994-09-15
Decision date: 1995-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: King Of Prussia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOZ

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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 Neostar Medical Technologies, Inc.

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K960625 — SPREADABLE SHEATH INTRODUCER SET1996-08-08
K941851 — DUAL LUMEN CATHETER (DLC) TRAY1995-03-13
K944660 — ACUTE CENTRAL VENOUS ACCESS CATHETER TRAY1995-03-13

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.