Cleared Traditional

K895734 - DESERET INTRAVASCULAR CATHETER

K895734 is the FDA 510(k) clearance for DESERET INTRAVASCULAR CATHETER by Deseret Medical, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K895734 · Deseret Medical, Inc. · General Hospital
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Apr 1990
Decision
195d
Days
Class 2
Risk

K895734 is an FDA 510(k) clearance for the DESERET INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Deseret Medical, Inc. (Sandy, US). The FDA issued a Cleared decision on April 9, 1990 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Deseret Medical, Inc. devices

Submission Details

510(k) Number K895734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date April 09, 1990
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 272
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K895734.
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
MULTICATH PLACEMENT KIT
K901640 · Vygon Corp. · Aug 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · Arrow Intl., Inc. · Jul 1990
STREAMLINE VASCULAR ACCESS DEVICE
K896774 · Menlo Care, Inc. · Dec 1989
OPTICALLY CLEAR RADIOPAQUE CATHETER
K893546 · Critikon Company, LLC · Nov 1989
PROLONG INTRAVASCULAR CATHETER
K893965 · Baxter Healthcare Corp · Sep 1989