Cleared Traditional

PRUITT ARTERIAL OCCLUSION CHOLANG. CATH (K812111) - FDA 510(k) Clearance

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

K812111 · Bionomy, Inc. · Cardiovascular device
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Nov 1981
Decision
112d
Days
Class 2
Risk

K812111 is an FDA 510(k) clearance for the PRUITT ARTERIAL OCCLUSION CHOLANG. CATH. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Bionomy, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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 Bionomy, Inc. devices

Submission Details

510(k) Number K812111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1981
Decision Date November 16, 1981
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 31
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K812111.
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982
MEDTRONIC S3 TM SYSTEM
K821004 · Medtronic Vascular · May 1982
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
K820702 · Instrumentation Laboratory CO · Apr 1982
TORQUE CONTROL BALLOON CATHETER
K802338 · Cordis Corp. · Oct 1980
CORDIS FLOW DIRECTED BALLOON CATHETER
K801865 · Cordis Corp. · Aug 1980
CATHETER, USCI GRUNTZIG/BALLOON
K782071 · C.R. Bard, Inc. · Dec 1978