Cleared Traditional

K964966 - V-CATH

K964966 is an FDA 510(k) clearance for V-CATH, manufactured by Hdc Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K964966 · Hdc Corp. · General Hospital
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Mar 1997
Decision
84d
Days
Class 2
Risk

K964966 is an FDA 510(k) clearance for the V-CATH. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Hdc Corp. (San Jose, US). The FDA issued a Cleared decision on March 5, 1997 after a review of 84 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hdc Corp. devices

FDA 510(k) Submission Details - K964966

510(k) Number K964966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1996
Decision Date March 05, 1997
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K964966.
FIRST MIDCATH CATHETER
K972254 · Becton Dickinson Infusion Therapy Systems, Inc. · Sep 1997
VYGON UMBILICAL CATHETHER INSERTION TRAY
K963196 · Vygon Corp. · Sep 1997
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K962577 · Arrow Intl., Inc. · Aug 1997
CVP POLYURETHANE CATHETER
K961552 · Abbott Laboratories · Feb 1997
FIRST MIDCATH CATHETER KIT
K964048 · Becton Dickinson Vascular Access, Inc. · Jan 1997
FIRST MIDCATH CATHETER WITH DUAL LUMENS
K964049 · Becton Dickinson Vascular Access, Inc. · Jan 1997