Cleared Traditional

K812111 - PRUITT ARTERIAL OCCLUSION CHOLANG. CATH

K812111 is an FDA 510(k) clearance for PRUITT ARTERIAL OCCLUSION CHOLANG. CATH, manufactured by Bionomy, Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 112-day FDA review.

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

FDA 510(k) Submission Details - K812111

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.

DYG Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K812111.
IL 7F FLOW DIRECTOR THERMAL DILU. CATH
K820702 · Instrumentation Laboratory CO · Apr 1982
SWAN-GANZ VIP-CATHETER
K820222 · American Edwards Laboratories · Feb 1982
NORTON FLOW DIRECTED THERMODILUTION CATH
K820229 · Norton Performance Plastics Corp. · Feb 1982
FLOW-DIRECTED THERMODILUTION CATHETER
K812324 · Sorensen Research · Sep 1981
SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
K812563 · American Edwards Laboratories · Sep 1981
SWAN-GANZ FLOW-DIRECTED THERMODILUTION
K810352 · American Edwards Laboratories · Mar 1981