Cleared Traditional

FLOW DIRECTED THERMODILUTION BALLOON CATHETER (K935404) - FDA 510(k) Clearance

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

K935404 · J-Lloyd Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
175d
Days
Class 2
Risk

K935404 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 May 3, 1994 after a review of 175 days - an extended review cycle.

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 J-Lloyd Medical, Inc. devices

Submission Details

510(k) Number K935404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date May 03, 1994
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 30
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K935404.
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063 · Baxter Healthcare Corp · Jul 2000
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816 · Baxter Healthcare Corp · May 1997
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
K951566 · Baxter Healthcare Corp · Nov 1995
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
SOFT-WEDGE(TM) SYRINGE
K900879 · Baxter Healthcare Corp · May 1990