Cleared Traditional

3-DAY BIOINDICATOR RELEASE PROCESS FOR (K833830) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833830 · Shiley, Inc. · Cardiovascular device
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Apr 1984
Decision
157d
Days
Class 2
Risk

K833830 is an FDA 510(k) clearance for the 3-DAY BIOINDICATOR RELEASE PROCESS FOR. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Shiley, Inc. (Walker, US). The FDA issued a Cleared decision on April 12, 1984 after a review of 157 days - an extended review 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: 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

Submission Details

510(k) Number K833830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1983
Decision Date April 12, 1984
Days to Decision 157 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
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 122
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K833830.
SHILEY CORONARY CARDIOPLEGIA ADAPTOR
K843542 · Shiley, Inc. · Oct 1984
ARGYLE CUSTOM TUBING PACK
K842889 · Sherwood Medical Co. · Aug 1984
ARGYLE TAPERED VASCULAR SHUNT
K840914 · Sherwood Medical Co. · Apr 1984
ARGYLE DUAL STAGE VENOUS RETURN CATH.
K831332 · Sherwood Medical Co. · Jun 1983
ARGYLE CAROTID ARTERY LOOP SHUNT
K822317 · Sherwood Medical Co. · Aug 1982
ARGYLE FERGUSON LEFT ATRIAL VENT CATH
K821445 · Sherwood Medical Co. · Jul 1982