DYG · Class II · 21 CFR 870.1240

FDA Product Code DYG: Catheter, Flow Directed

Leading manufacturers include Baxter Healthcare Corp, Medtronic Vascular and C.R. Bard, Inc..

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
1–24 of 99
Cleared Dec 09, 2024
HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)
K242451
Edwards Lifesciences
Cardiovascular · 115d
Cleared Jun 27, 2024
Swan-Ganz Pacing Probe and Catheters
K233983
Edwards Lifesciences
Cardiovascular · 192d
Cleared Jun 06, 2024
Swan-Ganz catheter
K233824
Edwards Lifesciences, LLC
Cardiovascular · 188d
Cleared Sep 21, 2023
Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
K231248
Edwards Lifesciencess, LLC
Cardiovascular · 143d
Cleared Dec 09, 2022
Swang-Ganz IQ pulmonary artery catheter
K222117
Edwards Lifesiences, LLC
Cardiovascular · 144d
Cleared Feb 16, 2020
Swan-Ganz Catheters
K193466
Edwards Lifesciences, LLC
Cardiovascular · 62d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225
Medtronic Vascular
Cardiovascular · 43d
Cleared Jul 07, 2000
SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7
K001063
Baxter Healthcare Corp
Cardiovascular · 95d
Cleared May 06, 1997
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR
K955816
Baxter Healthcare Corp
Cardiovascular · 497d
Cleared Nov 27, 1995
SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH]
K951566
Baxter Healthcare Corp
Cardiovascular · 237d
Cleared Jan 24, 1994
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742
Baxter Healthcare Corp
Cardiovascular · 112d
Cleared Oct 29, 1993
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452
Baxter Healthcare Corp
Cardiovascular · 422d
Cleared May 10, 1990
SOFT-WEDGE(TM) SYRINGE
K900879
Baxter Healthcare Corp
Cardiovascular · 73d
Cleared Feb 08, 1990
SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME
K896466
Baxter Healthcare Corp
Cardiovascular · 87d
Cleared Sep 05, 1989
BARD CATH LAB THERMODILUTION CATHETER
K893474
C.R. Bard, Inc.
Cardiovascular · 124d
Cleared May 25, 1988
SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
K874465
Abbott Laboratories
Cardiovascular · 208d
Cleared Nov 05, 1987
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117
Medtronic Vascular
Cardiovascular · 27d
Cleared Sep 17, 1985
BARD-PARKER OCCLUSION BALLOON CATHETER
K852294
Bd Becton Dickinson Vacutainer Systems Preanalytic
Cardiovascular · 111d
Cleared Aug 05, 1985
BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI
K850952
C.R. Bard, Inc.
Cardiovascular · 151d
Cleared Jun 20, 1985
MEDTRONIC MODEL 6404
K851948
Medtronic Vascular
Cardiovascular · 48d
Cleared Feb 04, 1984
IL HEPARINIZED FLOW DIRECTED THERMAL
K833836
Instrumentation Laboratory CO
Cardiovascular · 81d
Cleared Oct 20, 1983
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854
C.R. Bard, Inc.
Cardiovascular · 133d
Cleared Dec 22, 1982
THERMAL DILUTION CATHETER
K823484
Instrumentation Laboratory CO
Cardiovascular · 29d
Cleared May 25, 1982
MEDTRONIC S3 TM SYSTEM
K821004
Medtronic Vascular
Cardiovascular · 46d

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 →