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510(k) K940795

SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER by Baxter Edwards — Product Code DYG

K940795 is an FDA 510(k) premarket notification submitted by Baxter Edwards for the device "SWAN-GANZ CC0/SVO2 THERMODILUTION CATHETER". The FDA issued a decision of Substantially Equivalent on May 24, 1994. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Baxter Edwards has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1994
Date Received
February 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

Other clearances by Baxter Edwards

  • K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND P (May 4, 2000)
  • K981909 — BAXTER HEMOSTASIS VALVE INTRODUCERS (November 24, 1998)
  • K980487 — CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4 (July 7, 1998)
  • K965137 — FOGARTY VALVULOTOME MODEL 700091 (June 4, 1997)
  • K964021 — INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099) (March 27, 1997)
  • K955839 — MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (March 25, 1996)
  • K952638 — 4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE (July 28, 1995)
  • K944214 — BAXTER HANDLE MODEL 1150 (February 10, 1995)
  • K944858 — BAXTER EPTFE EXTERNALLY SUPPORTED VASCULAR GRAFTS (January 5, 1995)
  • K926433 — 4.5F IMAGECATH(R) CORONARY ANGIOSCOPE, COV45 (March 23, 1993)

Other clearances for product code DYG

  • K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphe (December 9, 2024)
  • K233983 — Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F (June 27, 2024)
  • K233824 — Swan-Ganz catheter (June 6, 2024)
  • K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanc (September 21, 2023)
  • K222117 — Swang-Ganz IQ pulmonary artery catheter (December 9, 2022)
  • K193466 — Swan-Ganz Catheters (February 16, 2020)
  • K160084 — Swan Ganz Catheters (May 3, 2016)
  • K094048 — PERCUPRO MESSENGER BALLOON CATHETER (July 14, 2011)
  • K081052 — OCCLUSION BALLOON CATHETER, MODEL VENOS (June 18, 2008)
  • K010253 — ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01; ANGIOFLOW METER, MODELS HQ (March 19, 2002)

FDA data resources