Home / 510(k) Clearances / K094048

510(k) K094048

PERCUPRO MESSENGER BALLOON CATHETER by Cardiosolutions, Inc. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2011
Date Received
December 31, 2009
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 Cardiosolutions, Inc.

  • K140015 — CARDIOSOLUTIONS DEXTERITY STEERABLE INTRODUCER (February 5, 2014)
  • K131332 — CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER (July 19, 2013)
  • K120086 — CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEER (April 24, 2012)
  • K094062 — PERCU-PRO GUIDEWIRE (September 27, 2010)

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)
  • 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)
  • K012225 — ATTAIN 6215 VENOGRAM BALLOON CATHETER (August 28, 2001)