FDA Product Code DYG: Catheter, Flow Directed
Leading manufacturers include Nova Medical Specialties, Baxter Healthcare Corp and American Edwards Laboratories.
99
Total
99
Cleared
107d
Avg days
1976
Since
Declining activity -
1 submissions in the last 2 years
vs 4 in the prior period
Consistent review times:
115d avg (recent)
FDA 510(k) Cleared Catheter, Flow Directed Devices (Product Code DYG)
99 devices
Cleared
Dec 09, 2024
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
Edwards Lifesciences
Cardiovascular
115d
Cleared
Jun 27, 2024
Swan-Ganz Pacing Probe and Catheters
Edwards Lifesciences
Cardiovascular
192d
Cleared
Jun 06, 2024
Swan-Ganz catheter
Edwards Lifesciences, LLC
Cardiovascular
188d
Cleared
Sep 21, 2023
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
Edwards Lifesciencess, LLC
Cardiovascular
143d
Cleared
Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
Edwards Lifesiences, LLC
Cardiovascular
144d
Cleared
Feb 16, 2020
Swan-Ganz Catheters
Edwards Lifesciences, LLC
Cardiovascular
62d
Cleared
May 03, 2016
Swan Ganz Catheters
Edwards Lifesciences, LLC
Cardiovascular
109d
Cleared
Jul 14, 2011
PERCUPRO MESSENGER BALLOON CATHETER
Cardiosolutions, Inc.
Cardiovascular
560d
Cleared
Jun 18, 2008
OCCLUSION BALLOON CATHETER, MODEL VENOS
Oscor, Inc.
Cardiovascular
65d
Cleared
Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
Transonic Systems, Inc.
Cardiovascular
417d
Cleared
Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
Medtronic Vascular
Cardiovascular
43d
Cleared
Dec 20, 2000
Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
Zcv ,Inc.
Cardiovascular
76d
Cleared
Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
Baxter Healthcare Corp
Cardiovascular
95d
Cleared
Oct 28, 1999
CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM
Alba Critical Care, Ltd.
Cardiovascular
30d
Cleared
Aug 14, 1997
HARMAC THERMODILUTION CATHETER
Harmac Medical Products, Inc.
Cardiovascular
412d
Cleared
May 06, 1997
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
Baxter Healthcare Corp
Cardiovascular
497d
Cleared
Feb 03, 1997
FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)
J-Lloyd Medical, Inc.
Cardiovascular
168d
Cleared
Nov 19, 1996
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
Boston Scientific Scimed, Inc.
Cardiovascular
181d
Cleared
Nov 27, 1995
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
Baxter Healthcare Corp
Cardiovascular
237d
Cleared
Aug 11, 1994
FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED
J-Lloyd Medical, Inc.
Cardiovascular
185d
Cleared
May 24, 1994
SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER
Baxter Edwards
Cardiovascular
91d
Cleared
May 03, 1994
FLOW DIRECTED THERMODILUTION BALLOON CATHETER
J-Lloyd Medical, Inc.
Cardiovascular
175d
Cleared
Jan 24, 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
Baxter Healthcare Corp
Cardiovascular
112d
Cleared
Oct 29, 1993
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
Baxter Healthcare Corp
Cardiovascular
422d
About Product Code DYG - Regulatory Context
510(k) Submission Activity
99 total 510(k) submissions under product code DYG since 1976, with 99 receiving FDA clearance (average review time: 107 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - DYG Product Code
FDA review times for DYG submissions have been consistent, averaging 115 days recently vs 107 days historically.
DYG devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →