Cleared Traditional

K895191 - ANTI-THROMBOGENIC COATING FOR CATHETERS

K895191 is an FDA 510(k) clearance for ANTI-THROMBOGENIC COATING FOR CATHETERS, manufactured by Burron Medical, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K895191 · Burron Medical, Inc. · General Hospital
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Nov 1989
Decision
105d
Days
Class 2
Risk

K895191 is an FDA 510(k) clearance for the ANTI-THROMBOGENIC COATING FOR CATHETERS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Burron Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 24, 1989 after a review of 105 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 Burron Medical, Inc. devices

FDA 510(k) Submission Details - K895191

510(k) Number K895191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1989
Decision Date November 24, 1989
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 417
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K895191.
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K895734 · Deseret Medical, Inc. · Apr 1990
EXEL SAFELET CATHETER
K895768 · Exel Intl. · Feb 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
PROCEDURE READY TRAYS
K884577 · Professional Medical Services · Aug 1989