Cleared Traditional

K880103 - CATHETER

K880103 is an FDA 510(k) clearance for CATHETER, manufactured by Research Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K880103 · Research Medical, Inc. · Cardiovascular device
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Mar 1988
Decision
70d
Days
Class 2
Risk

K880103 is an FDA 510(k) clearance for the CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - the FDA cardiovascular device oversight 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 Research Medical, Inc. devices

FDA 510(k) Submission Details - K880103

510(k) Number K880103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1988
Decision Date March 22, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 125d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 270
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K880103.
MEDSURG 16 GA. CENTRAL VEIN CATHETERIZATION TRAY
K880779 · Medsurg Industries, Inc. · May 1988
DESCENDING ARCH CANNULA
K880421 · Dlp, Inc. · Apr 1988
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K875353 · Dlp, Inc. · Mar 1988
SARNS VENOATRIAL CATHETER
K875048 · 3M Health Care, Sarns · Feb 1988
SARNS VISIFLOW AORTIC ARCH CANNULA
K874896 · 3M Health Care, Sarns · Feb 1988
ARGYLE CARDIOPLEGIA CANNULA
K874834 · Sherwood Medical Co. · Jan 1988