Cleared Traditional

K873050 - VASCULAR ACCESS CATHETER W/ANTIMICROBIA...

K873050 is the FDA 510(k) clearance for VASCULAR ACCESS CATHETER W/ANTIMICROBIA... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K873050 · C.R. Bard, Inc. · General Hospital
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Oct 1987
Decision
77d
Days
Class 2
Risk

K873050 is an FDA 510(k) clearance for the VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 77 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K873050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date October 20, 1987
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K873050.
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · Baxter Healthcare Corp · Jun 1988
HR(TM) INTRAVASCULAR CATHETER
K881666 · Icu Medical, Inc. · May 1988
J&J SCALP VEIN INFUSION SETS
K875177 · Critikon Company, LLC · Jan 1988
CHURCHILL-CATH
K872585 · Churchill Corp. · Oct 1987
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
K870403 · Burron Medical Products, Inc. · May 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · Quinton, Inc. · Feb 1987