DYG — Catheter, Flow Directed Class II
FDA product code DYG covers "Catheter, Flow Directed", a Class II medical device regulated under 21 CFR 870.1240. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |