Cleared Traditional

K840603 - ARTERIAL FILTER PURGE LINE W/CHECK VALV

K840603 is an FDA 510(k) clearance for ARTERIAL FILTER PURGE LINE W/CHECK VALV, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K840603 · Shiley, Inc. · Cardiovascular device
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Apr 1984
Decision
69d
Days
Class 2
Risk

K840603 is an FDA 510(k) clearance for the ARTERIAL FILTER PURGE LINE W/CHECK VALV. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K840603

510(k) Number K840603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1984
Decision Date April 19, 1984
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 85
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K840603.
FILTER PURGE LINE EC-FPL SERIES
K833644 · Gish Biomedical, Inc. · Dec 1984
HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS
K842829 · North American Instrument Corp. · Oct 1984
MALE-MALE LUER LOCK CONNECTOR W/ROTA
K840797 · American Pharmaseal Div. Ahsc · Apr 1984
TUBING CONNECTORS EC-2XXX SERIES
K833322 · Gish Biomedical, Inc. · Dec 1983
SCI MED TEMPERATURE MONITORING ADAPTOR
K831260 · Scimed Life Systems, Inc. · Jun 1983
SCI MED TUBING CONNECTORS
K831261 · Scimed Life Systems, Inc. · Jun 1983