Cleared Traditional

K923702 - INTIMA POINT GUARD INTRAVASCULAR CATHETER

K923702 is an FDA 510(k) clearance for INTIMA POINT GUARD INTRAVASCULAR CATHETER, manufactured by Becton Dickinson Vascular Access, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 425-day FDA review.

K923702 · Becton Dickinson Vascular Access, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
425d
Days
Class 2
Risk

K923702 is an FDA 510(k) clearance for the INTIMA POINT GUARD INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on September 22, 1993 after a review of 425 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Becton Dickinson Vascular Access, Inc. devices

FDA 510(k) Submission Details - K923702

510(k) Number K923702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 129d · This submission: 425d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 299
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K923702.
CATH-FINDER
K931073 · Pharmacia Deltec, Inc. · May 1994
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K926544 · Pharmacia Deltec, Inc. · Mar 1994
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050 · Critikon Company, LLC · Dec 1993
SAFEDWEL(R) CENTRAL VENOUS CATHETER
K914528 · Becton Dickinson Vascular Access, Inc. · Oct 1992
SAFE-DWELL PLUS CENTRAL VENOUS CATHETER
K921270 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1992
SAFE-PICC PERIPHERALLY INSERTED CENTRAL VENOUS CAT
K920828 · Menlo Care, Inc. · Aug 1992