INTIMA POINT GUARD INTRAVASCULAR CATHETER— 510(k) K923702

Name: FDA 510(k) clearance K923702
Creator: U.S. Food and Drug Administration
Published: 1993-09-22

Substantially Equivalent

Becton Dickinson Vascular Access, Inc.

FDA 510(k) clearance K923702 for INTIMA POINT GUARD INTRAVASCULAR CATHETER, Substantially Equivalent on 1993-09-22. Applicant: Becton Dickinson Vascular Access, Inc.. Device class: 2.

Clearance details

Applicant: Becton Dickinson Vascular Access, Inc.
Product code: Code FOZ
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1992-07-24
Decision date: 1993-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOZ

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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 Becton Dickinson Vascular Access, Inc.

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K971339 — INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS1997-12-24
K970259 — E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET1997-04-08
K964048 — FIRST MIDCATH CATHETER KIT1997-01-06
K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS1997-01-06
K964050 — FIRST MIDCATH CATHETER1997-01-06

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.