Product code DYG
- Device name
- Catheter, Flow Directed
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1240
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P810046S215 | RX CHASSIS 3 CORONARY DILATATION CATHETER | Advanced Cardiovascular Systems, Inc. | 2004-07-16 |
| P810046S214 | VOYAGER OTW CORONARY DILATION CATHETER | Advanced Cardiovascular Systems, Inc. | 2004-03-12 |
| P810046S213 | ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS | Advanced Cardiovascular Systems, Inc. | 2002-10-23 |
| P810046S212 | HIGHSAIL CORONARY DILATATION CATHETERS | Advanced Cardiovascular Systems, Inc. | 2002-05-10 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences | 2024-12-09 |
| K233983 | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) | Edwards Lifesciences | 2024-06-27 |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | 2024-06-06 |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | 2023-09-21 |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | 2022-12-09 |
| K193466 | Swan-Ganz Catheters | Edwards Lifesciences, LLC | 2020-02-16 |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | 2016-05-03 |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | 2011-07-14 |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | Oscor, Inc. | 2008-06-18 |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Transonic Systems, Inc. | 2002-03-19 |
| K012225 | ATTAIN 6215 VENOGRAM BALLOON CATHETER | Medtronic Vascular | 2001-08-28 |
| K003118 | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | Zcv ,Inc. | 2000-12-20 |
| K001063 | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | Baxter Healthcare Corp | 2000-07-07 |
| K993245 | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM | Alba Critical Care, Ltd. | 1999-10-28 |
| K963336 | HARMAC THERMODILUTION CATHETER | Harmac Medical Products, Inc. | 1997-08-14 |
| K955816 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | Baxter Healthcare Corp | 1997-05-06 |
| K963248 | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | J-Lloyd Medical, Inc. | 1997-02-03 |
| K961999 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1996-11-19 |
| K951566 | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] | Baxter Healthcare Corp | 1995-11-27 |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | J-Lloyd Medical, Inc. | 1994-08-11 |
| K940795 | SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER | Baxter Edwards | 1994-05-24 |
| K935404 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1994-05-03 |
| K934742 | SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT | Baxter Healthcare Corp | 1994-01-24 |
| K924452 | SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER | Baxter Healthcare Corp | 1993-10-29 |
| K925444 | CARDIAC OUTPUT PULMONARY ARTERY CATHETER & MONITOR | Ami-Med Corp. | 1993-07-19 |
| K920869 | FLOW DIRECTED THERMODILUTION BALLOON CATHETER | J-Lloyd Medical, Inc. | 1993-01-13 |
| K911840 | INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER | Intec Medical, Inc. | 1991-06-03 |
| K901287 | INTHERM TEMPORARY OCCLUSION CATHETER | Interventional Therapeutics Corp. | 1991-02-20 |
| K904287 | STEALTH DILATION CATHETER SYSTEM/MODIFICATION | Target Therapeutics | 1991-01-16 |
| K901247 | TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES | Intec Medical, Inc. | 1990-07-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885403522386 | Swan-Ganz | Becton, Dickinson And Company | 2026-05-30 |
| 00885403522348 | SWAN-GANZ CCOMBO V | Becton, Dickinson And Company | 2026-05-30 |
| 00885403522270 | Swan-Ganz | Becton, Dickinson And Company | 2026-05-30 |
| 00690103218602 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2026-03-16 |
| 00690103218626 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2026-03-16 |
| 00690103218633 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2026-03-16 |
| 10801902160673 | ARROW | TELEFLEX INCORPORATED | 2019-12-21 |
| 10801902160598 | ARROW | TELEFLEX INCORPORATED | 2019-12-19 |
| 10801902160666 | ARROW | TELEFLEX INCORPORATED | 2019-12-19 |
| 10801902160604 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160581 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160574 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160567 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160550 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160543 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160529 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902160536 | ARROW | TELEFLEX INCORPORATED | 2019-12-11 |
| 10801902128871 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902128888 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 10801902128895 | ARROW | TELEFLEX INCORPORATED | 2016-09-16 |
| 00690103000269 | SWAN-GANZ | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000313 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000276 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000245 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 08717648176524 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176500 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176470 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176463 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176449 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |
| 08717648176340 | Graftmaster | ABBOTT VASCULAR INC. | 2014-11-21 |