Cleared Traditional

INTIMA POINT GUARD INTRAVASCULAR CATHETER

K923702 · Becton Dickinson Vascular Access, Inc. · General Hospital

Sep 1993

Decision

425d

Days

Class 2

Risk

About This 510(k) Submission

K923702 is an FDA 510(k) clearance for the INTIMA POINT GUARD INTRAVASCULAR CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on September 22, 1993, 425 days after receiving the submission on July 24, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K923702 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 1992
Decision Date	September 22, 1993
Days to Decision	425 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200