Cleared Traditional

K893965 - PROLONG INTRAVASCULAR CATHETER

K893965 is the FDA 510(k) clearance for PROLONG INTRAVASCULAR CATHETER by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K893965 · Baxter Healthcare Corp · General Hospital
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Sep 1989
Decision
98d
Days
Class 2
Risk

K893965 is an FDA 510(k) clearance for the PROLONG INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 8, 1989 after a review of 98 days - within the typical 510(k) review window.

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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K893965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1989
Decision Date September 08, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
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 265
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K893965.
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
TERUMO SURFLO(R) I.V. CATHETER
K891087 · Terumo Medical Corp. · Jun 1989
SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE
K884325 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1989
CATH-FINDER SYSTEM
K884701 · Pharmacia Deltec, Inc. · Feb 1989