Cleared Traditional

K940795 - SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER

K940795 is an FDA 510(k) clearance for SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER, manufactured by Baxter Edwards. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K940795 · Baxter Edwards · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
91d
Days
Class 2
Risk

K940795 is an FDA 510(k) clearance for the SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Baxter Edwards (Irvine, US). The FDA issued a Cleared decision on May 24, 1994 after a review of 91 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 Baxter Edwards devices

FDA 510(k) Submission Details - K940795

510(k) Number K940795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1994
Decision Date May 24, 1994
Days to Decision 91 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
34d faster than avg
Panel avg: 125d · This submission: 91d
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 K940795.
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K961999 · Boston Scientific Scimed, Inc. · Nov 1996
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
K951566 · Baxter Healthcare Corp · Nov 1995
FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
K940547 · J-Lloyd Medical, Inc. · Aug 1994
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