Cleared Traditional

K920869 - FLOW DIRECTED THERMODILUTION BALLOON CATHETER

K920869 is an FDA 510(k) clearance for FLOW DIRECTED THERMODILUTION BALLOON CA..., manufactured by J-Lloyd Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K920869 · J-Lloyd Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
323d
Days
Class 2
Risk

K920869 is an FDA 510(k) clearance for the FLOW DIRECTED THERMODILUTION BALLOON CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by J-Lloyd Medical, Inc. (West Berlin, US). The FDA issued a Cleared decision on January 13, 1993 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 J-Lloyd Medical, Inc. devices

FDA 510(k) Submission Details - K920869

510(k) Number K920869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date January 13, 1993
Days to Decision 323 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 125d · This submission: 323d
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 68
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K920869.
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
K935404 · J-Lloyd Medical, Inc. · May 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452 · Baxter Healthcare Corp · Oct 1993
INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
K911840 · Intec Medical, Inc. · Jun 1991
INTHERM TEMPORARY OCCLUSION CATHETER
K901287 · Interventional Therapeutics Corp. · Feb 1991
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287 · Target Therapeutics · Jan 1991