Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1240](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1240) → DYG — Catheter, Flow Directed # DYG · Catheter, Flow Directed _Cardiovascular · 21 CFR 870.1240 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG ## Overview - **Product Code:** DYG - **Device Name:** Catheter, Flow Directed - **Regulation:** [21 CFR 870.1240](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1240) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K242451.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K233983.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K233824.md) | Swan-Ganz catheter | Edwards Lifesciences, LLC | Jun 6, 2024 | SESE | | [K231248](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K231248.md) | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform | Edwards Lifesciencess, LLC | Sep 21, 2023 | SESE | | [K222117](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K222117.md) | Swang-Ganz IQ pulmonary artery catheter | Edwards Lifesiences, LLC | Dec 9, 2022 | SESE | | [K193466](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K193466.md) | Swan-Ganz Catheters | Edwards Lifesciences, LLC | Feb 16, 2020 | SESE | | [K160084](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K160084.md) | Swan Ganz Catheters | Edwards Lifesciences, LLC | May 3, 2016 | SESE | | [K094048](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K094048.md) | PERCUPRO MESSENGER BALLOON CATHETER | Cardiosolutions, Inc. | Jul 14, 2011 | SESE | | [K081052](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K081052.md) | OCCLUSION BALLOON CATHETER, MODEL VENOS | Oscor, Inc. | Jun 18, 2008 | SESE | | [K010253](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K010253.md) | ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ100 AND HQ101 | Transonic Systems, Inc. | Mar 19, 2002 | SESE | | [K012225](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K012225.md) | ATTAIN 6215 VENOGRAM BALLOON CATHETER | Medtronic Vascular | Aug 28, 2001 | SESE | | [K003118](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K003118.md) | Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0 | Zcv ,Inc. | Dec 20, 2000 | SESE | | [K001063](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K001063.md) | SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 | Baxter Healthcare Corp | Jul 7, 2000 | SESE | | [K993245](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K993245.md) | CONTINOUS CARDIAC OUTPUT PULMONARY ARTERY CATHETER, MODEL TRUCATH, CONTINOUS CARDIAC OUTPUT MONITOR, MODEL TRUCCOM | Alba Critical Care, Ltd. | Oct 28, 1999 | SESE | | [K963336](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K963336.md) | HARMAC THERMODILUTION CATHETER | Harmac Medical Products, Inc. | Aug 14, 1997 | SESE | | [K955816](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K955816.md) | VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR | Baxter Healthcare Corp | May 6, 1997 | SESE | | [K963248](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K963248.md) | FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) | J-Lloyd Medical, Inc. | Feb 3, 1997 | SESE | | [K961999](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K961999.md) | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | Nov 19, 1996 | SESE | | [K951566](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K951566.md) | 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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG/K940547.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DYG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com