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Panels › Cardiovascular › Product code DYG · Class 2

Catheter, Flow Directed

Regulation 870.1240

0510(k)s in 12 months (99 all time)
2recalls in 12 months (49 all time)
47recalls that name a 510(k)
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Top companies in DYG

Company510(k)sRecalls
Edwards Lifesciences520
B. Braun Medical, Inc.021
Baxter Healthcare Corp70
Nova Medical Specialties70
American Edwards Laboratories60
C.R. Bard, Inc.40
J-Lloyd Medical, Inc.40
Medtronic Vascular40
Arrow International Inc03
Critikon Company, LLC30
Decided510(k)Device and applicantCode
Jun 11, 1984K841317DESERET HEPARIN COATED FLOW DIRECTED
Parke-Davis Co.
DYG
Jun 11, 1984K841251DESERET HEPARIN COATED FLOW CATH
Parke-Davis Co.
DYG
Feb 4, 1984K833836IL HEPARINIZED FLOW DIRECTED THERMAL
Instrumentation Laboratory CO
DYG
Jan 30, 1984K833918INFUSION PORT BALLOON THERMODILUTION
Critikon Company, LLC
DYG
Jan 30, 1984K833572HEPARIN-COATED BALLOON THERMODILUT
Critikon Company, LLC
DYG
Jan 10, 1984K834037HEPARIN COATED BALLOON THERMODILU
Nova Medical Specialties
DYG
Jan 10, 1984K834036HEPARIN COATED BALLOON THERMODILU
Nova Medical Specialties
DYG
Nov 28, 1983K832380PROTECTIVE SLEEVE
Vertex Medical Corp.
DYG
Nov 3, 1983K832324THERMAL DILUTION CATHETER
Catheter Corp. of America
DYG
Oct 20, 1983K831854USCI ANGIOGRAPHIC BALLOON CATHETER
C.R. Bard, Inc.
DYG
Oct 19, 1983K832287NOVA BALLOON THERMODILUTION INFUSION
Nova Medical Specialties
DYG
Sep 29, 1983K832957FLOW-DIRECTED HEPARIN COATED THERMODIL
Sorensen Research
DYG
Aug 12, 1983K831945ELECATH BALTHERM TLC THERMAL DILUTION
Electro-Catheter Corp.
DYG
Jul 18, 1983K830604WEDGE PRESSURE CATHETER
Plasmedics, Inc.
DYG
May 27, 1983K831185CARDIAC OUTPUT MEASURE SYSTEM
Cook, Inc.
DYG
Dec 22, 1982K823484THERMAL DILUTION CATHETER
Instrumentation Laboratory CO
DYG
Nov 30, 1982K823433BALLOON THERMODILUTION CATHETER #7164&
Critikon Company, LLC
DYG
Nov 1, 1982K823007OPTICATH HEPARIN COATED, FLOW-DIRECT
Oximetrix, Inc.
DYG
Nov 1, 1982K822806BALLOON WEDGE PRESSURE, ANGIOGRAPHIC
Nova Medical Specialties
DYG
Oct 15, 1982K822723SWAN-GANZ BIPOLAR PACING CATHETER
American Edwards Laboratories
DYG
Aug 24, 1982K822350SWAN-GANZ FLOW-DIRECTED THERMODIL. CATH
American Edwards Laboratories
DYG
Aug 24, 1982K822034BALLOON WEDGE PRESSURE CATHETER
Ziehm International, Inc.
DYG
Jul 30, 1982K821996LEONARD PERIPHERAL VENOUS PRESSURE CATH
Norton Performance Plastics Corp.
DYG
May 25, 1982K821004MEDTRONIC S3 TM SYSTEM
Medtronic Vascular
DYG
May 18, 1982K821235HEPARIN COATED THERMODILUTION CATHETER
Gould, Inc.
DYG
May 18, 1982K821099HEPARIN COATED THERMODILUTION CATHETER
Kma, Inc.
DYG
May 18, 1982K821057FLOW DIRECTED THERMAL-DILUTION INFUSION
Oximetrix, Inc.
DYG
Apr 29, 1982K820883SEPTISLEEVE
Argon Medical Corp.
DYG
Apr 21, 1982K820702IL 7F FLOW DIRECTOR THERMAL DILU. CATH
Instrumentation Laboratory CO
DYG
Feb 12, 1982K820229NORTON FLOW DIRECTED THERMODILUTION CATH
Norton Performance Plastics Corp.
DYG
Feb 12, 1982K820222SWAN-GANZ VIP-CATHETER
American Edwards Laboratories
DYG
Jan 18, 1982K813578HEMOSTATIC SIDE-ARM ADAPTER
Advanced Catheter Systems
DYG
Nov 16, 1981K812111PRUITT ARTERIAL OCCLUSION CHOLANG. CATH
Bionomy, Inc.
DYG
Sep 25, 1981K812563SWAN-GANZ & EDSLAB HEPARIN COATED CATH.
American Edwards Laboratories
DYG
Sep 25, 1981K812324FLOW-DIRECTED THERMODILUTION CATHETER
Sorensen Research
DYG
Jun 30, 1981K811276OCCLUSION CATHETER
Bionomy, Inc.
DYG
Mar 27, 1981K810352SWAN-GANZ FLOW-DIRECTED THERMODILUTION
American Edwards Laboratories
DYG
Feb 4, 1981K810124SWAN-GANZ VIP THERMODILUTION CATHETER
American Edwards Laboratories
DYG
Nov 20, 1980K802288SWAN GANZ CATHETER PLACEMENT KIT
Stanco Medical, Inc.
DYG
Oct 31, 1980K8024817FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
Waters Assoc., Inc.
DYG
Oct 10, 1980K802338TORQUE CONTROL BALLOON CATHETER
Cordis Corp.
DYG
Aug 20, 1980K801865CORDIS FLOW DIRECTED BALLOON CATHETER
Cordis Corp.
DYG
Dec 15, 1978K782071CATHETER, USCI GRUNTZIG/BALLOON
C.R. Bard, Inc.
DYG
Dec 20, 1977K771823CATHETER, CARDIOVASCULAR
Usci, Div. C.R. Bard, Inc.
DYG
Dec 20, 1977K771043SWAN GANZ
Clincal Instruments Corp.
DYG
Nov 15, 1977K772059CATHETER, PACING/MONITORING
Electro-Catheter Corp.
DYG
Sep 14, 1977K771306THERMOCATH
Victory Engineering Corp.
DYG
Mar 30, 1977K770522CATHETER, GRUNTZIG, BALLON
Cook, Inc.
DYG
Sep 9, 1976K760533CATHETER, FLOW DIRECTED THERMAL DILUTION
Gould, Inc.
DYG

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