DYG · Catheter, Flow Directed
Cardiovascular · 21 CFR 870.1240 · Class 2
Overview
| Product Code | DYG |
|---|---|
| Device Name | Catheter, Flow Directed |
| Regulation | 21 CFR 870.1240 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 99)
Showing 20 most recent of 99 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) | Edwards Lifesciences | Dec 9, 2024 | SESE |
| 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 | Jun 27, 2024 | SESE |
| K233824 | Swan-Ganz catheter | Edwards Lifesciences, LLC | Jun 6, 2024 | SESE |
| K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | Sep 21, 2023 | SESE |
| K222117 | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | Dec 9, 2022 | SESE |
| K193466 | Swan-Ganz Catheters | Edwards Lifesciences, LLC | Feb 16, 2020 | SESE |
| K160084 | Swan Ganz Catheters | Edwards Lifesciences, LLC | May 3, 2016 | SESE |
| K094048 | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | Jul 14, 2011 | SESE |
| K081052 | OCCLUSION BALLOON CATHETER, MODEL VENOS | Oscor, Inc. | Jun 18, 2008 | SESE |
| K010253 | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Transonic Systems, Inc. | Mar 19, 2002 | SESE |
| K012225 | ATTAIN 6215 VENOGRAM BALLOON CATHETER | Medtronic Vascular | Aug 28, 2001 | SESE |
| K003118 | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | Zcv ,Inc. | Dec 20, 2000 | SESE |
| K001063 | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | Baxter Healthcare Corp | Jul 7, 2000 | SESE |
| K993245 | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM | Alba Critical Care, Ltd. | Oct 28, 1999 | SESE |
| K963336 | HARMAC THERMODILUTION CATHETER | Harmac Medical Products, Inc. | Aug 14, 1997 | SESE |
| K955816 | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | Baxter Healthcare Corp | May 6, 1997 | SESE |
| K963248 | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | J-Lloyd Medical, Inc. | Feb 3, 1997 | SESE |
| K961999 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | Nov 19, 1996 | SESE |
| K951566 | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] | Baxter Healthcare Corp | Nov 27, 1995 | SESE |
| K940547 | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | J-Lloyd Medical, Inc. | Aug 11, 1994 | SESE |
Top Applicants
- Baxter Healthcare Corp — 7 clearances
- Nova Medical Specialties — 7 clearances
- American Edwards Laboratories — 6 clearances
- C.R. Bard, Inc. — 4 clearances
- J-Lloyd Medical, Inc. — 4 clearances
