DYG — Catheter, Flow Directed Class II
FDA Device Classification
Classification Details
- Product Code
- DYG
- Device Class
- Class II
- Regulation Number
- 870.1240
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K242451 | edwards lifesciences | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphe | December 9, 2024 |
| K233983 | edwards lifesciences | Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F | June 27, 2024 |
| K233824 | edwards lifesciences | Swan-Ganz catheter | June 6, 2024 |
| K231248 | edwards lifesciencess | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanc | September 21, 2023 |
| K222117 | edwards lifesiences | Swang-Ganz IQ pulmonary artery catheter | December 9, 2022 |
| K193466 | edwards lifesciences | Swan-Ganz Catheters | February 16, 2020 |
| K160084 | edwards lifesciences | Swan Ganz Catheters | May 3, 2016 |
| K094048 | cardiosolutions | PERCUPRO MESSENGER BALLOON CATHETER | July 14, 2011 |
| K081052 | oscor | OCCLUSION BALLOON CATHETER, MODEL VENOS | June 18, 2008 |
| K010253 | transonic systems | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ | March 19, 2002 |
| K012225 | medtronic vascular | ATTAIN 6215 VENOGRAM BALLOON CATHETER | August 28, 2001 |
| K003118 | zcv | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | December 20, 2000 |
| K001063 | baxter healthcare | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7 | July 7, 2000 |
| K993245 | alba critical care | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CAR | October 28, 1999 |
| K963336 | harmac medical products | HARMAC THERMODILUTION CATHETER | August 14, 1997 |
| K955816 | baxter healthcare | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | May 6, 1997 |
| K963248 | j-lloyd medical | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | February 3, 1997 |
| K961999 | boston scientific scimed | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | November 19, 1996 |
| K951566 | baxter healthcare | SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRAC | November 27, 1995 |
| K940547 | j-lloyd medical | FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED | August 11, 1994 |