Cleared Traditional

K862153 - ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/2...

K862153 is an FDA 510(k) clearance for ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/2..., manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K862153 · Arrow Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1986
Decision
189d
Days
Class 2
Risk

K862153 is an FDA 510(k) clearance for the ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on December 11, 1986 after a review of 189 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K862153

510(k) Number K862153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1986
Decision Date December 11, 1986
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 278
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K862153.
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
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · Parke-Davis Co. · Dec 1986
COMFORT-SET* I.V. CATHETER PLACEMENT UNIT.
K862130 · Menlo Care, Inc. · Aug 1986
CAVAFIX, CENTRAL VENOUS CATHETER KIT
K861479 · Burron Medical Products, Inc. · Jul 1986