ClearanceBrief
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
DateFirm and productCodeLinked 510(k)
May 15, 2026Becton, Dickinson and Company
Swan-Ganz Pacing Catheter, Models: D200F7;
Open, Classified		 DYGK233983
May 15, 2026Becton, Dickinson and Company
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Open, Classified		 DYGK231248
May 12, 2025LeMaitre Vascular, Inc.
Pruitt Occlusion Catheter. Catalog Numbers: 2103-36, 2103-46, 2103-56, E2103-36, E2103-46, E2103-56
Open, Classified		 DYGK811276
Apr 12, 2023Edwards Lifesciences, LLC
Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimu
Open, Classified		 DYGNone listed
Apr 12, 2023Edwards Lifesciences, LLC
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum I
Open, Classified		 DYGNone listed
Nov 15, 2019Arrow International Inc
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Terminated		 DYGK892530
Nov 15, 2019Arrow International Inc
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Terminated		 DYGK892530
Jan 31, 2019Edwards Lifesciences, LLC
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic press
Terminated		 DYGK160084
Jan 31, 2019Edwards Lifesciences, LLC
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pre
Terminated		 DYGK160084
Jan 31, 2019Edwards Lifesciences, LLC
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determin
Terminated		 DYGK160084
Jan 31, 2019Edwards Lifesciences, LLC
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pres
Terminated		 DYGK160084
Jun 2, 2015Edwards Lifesciences, LLC
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic vo
Terminated		 DYGK940795
Apr 4, 2013Arrow International Inc
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Angiographic Catheter is indicated for use in right heart catheteriz
Terminated		 DYGK892530
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK812563
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Aug 12, 2012Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
Terminated		 DYGK810352
Apr 17, 2009Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One cat
Terminated		 DYGK934742
Apr 17, 2009Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8 For use in
Terminated		 DYGK934742
Apr 17, 2009Edwards Lifesciences, Llc
Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC THROMBOSHIELD (an Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One cathete
Terminated		 DYGK924452
Jul 23, 2007B. Braun Medical, Inc.
Thermodilution Right Heart Catheters, Catalog Numbers 604028 and 604165. The product is shipped 5 units per carton.-B. Braun Medical, Allentown, Pa.
Terminated		 DYGK832287
Jan 5, 2007Edwards Lifesciences Technology SARL
Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
Terminated		 DYGK812563
Aug 2, 2006Edwards Lifesciences Llc
EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only. Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM.
Terminated		 DYGK902628
K924452 +2
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 608055-------------827D1006I 4P BBM RMM Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 608054------------827D1006I 4P BBM RMM Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604315-------------406-1H-018 426D1009I18PP.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604264-------------427D1006I Round Molded Manifold.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604239-------------426D1009I.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604165-------------T047-04 0427D1022I.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604103-------------T047(97) 427D4036I.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604100-----------T147-03 A427D1014 KANI 25PP.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604057---------------T147 A427D1014KANI
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604037------T047-02 0427D10061.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604028------------T047(90) 427D1022I.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604025------------T046-02 0426D1009I RMM.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 604000------417D1006I.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601293------------WP1107S Monitory Wedge Press.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601285-----WP11055 Wedge Press Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601276 ----WP1107 Wedge Press Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601272------WP1106 Wedge Press Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601261-----WP605P Wedge Press Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601258----WP604P Wedge Press Cath.
Terminated		 DYGK822806
K832287 +1
Jul 16, 2005B. Braun Medical, Inc.
Right Heart Catheter Product Line: Catalog Number 601129-----5011094 0106 x 1007BBMWS.
Terminated		 DYGK822806
K832287 +1
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
Pentalumen TD Thermodilution Catheter, Sterile
Terminated		 DYGK812800
K832957

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