Cleared Traditional

K843232 - SHILEY HARDSHELL VENOUS RESERVOIR W/INT

K843232 is an FDA 510(k) clearance for SHILEY HARDSHELL VENOUS RESERVOIR W/INT, manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K843232 · Shiley, Inc. · Cardiovascular device
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Jan 1985
Decision
150d
Days
Class 2
Risk

K843232 is an FDA 510(k) clearance for the SHILEY HARDSHELL VENOUS RESERVOIR W/INT. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shiley, Inc. devices

FDA 510(k) Submission Details - K843232

510(k) Number K843232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1984
Decision Date January 14, 1985
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K843232.
VENUOS RESERVOIR BAG BMR-1900
K851401 · American Bentley · Jun 1985
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391 · Electromedics, Inc. · May 1985
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · Gish Biomedical, Inc. · Feb 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229 · Gish Biomedical, Inc. · Jan 1985
CARDIOTOMY RESERVOIR BCR-2000
K844366 · American Bentley · Jan 1985
CARDIOTOMY RESERVOIR W/FILTER BCR-2500
K844367 · American Bentley · Jan 1985