Cleared Traditional

K861479 - CAVAFIX, CENTRAL VENOUS CATHETER KIT

K861479 is an FDA 510(k) clearance for CAVAFIX, manufactured by Burron Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K861479 · Burron Medical Products, Inc. · General Hospital
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Jul 1986
Decision
70d
Days
Class 2
Risk

K861479 is an FDA 510(k) clearance for the CAVAFIX, CENTRAL VENOUS CATHETER KIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Bethlehem, US). The FDA issued a Cleared decision on July 1, 1986 after a review of 70 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 Burron Medical Products, Inc. devices

FDA 510(k) Submission Details - K861479

510(k) Number K861479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 22, 1986
Decision Date July 01, 1986
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
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 344
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K861479.
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · Parke-Davis Co. · Dec 1986
SUPERCATH I.V. CATHETER
K864038 · Togo Medikit Co., Ltd. · Dec 1986
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.
K862130 · Menlo Care, Inc. · Aug 1986
ANTHRON CATHETERS & SETS
K861117 · Toray Industries (America), Inc. · Jun 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510 · Warner-Lambert Co. · Jun 1986
STREAM LINE* I.V. CATHETER PLACEMENT UNIT
K860474 · Menlo Care, Inc. · May 1986