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510(k) K792348

STANICOR, OMNI-STAN,MOD 333B,334A GAMMA by Cordis Corp. — Product Code DTX

K792348 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "STANICOR, OMNI-STAN,MOD 333B,334A GAMMA". The FDA issued a decision of Substantially Equivalent on December 5, 1979. The device falls under product code DTX (Gas Control Unit, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4300. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1979
Date Received
November 19, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
Submission Type

Other clearances by Cordis Corp.

  • K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EX (March 12, 2014)
  • K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (May 4, 2012)
  • K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (July 9, 2010)
  • K082143 — MICRO GUIDE CATHETER XP (August 25, 2008)
  • K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB (February 6, 2008)
  • K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,B (April 27, 2006)
  • K050645 — CORDIS AMIIA .014 PTA BALLOON CATHETER (April 1, 2005)
  • K040592 — CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (December 17, 2004)
  • K042969 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (November 8, 2004)
  • K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTE (December 22, 2003)

Other clearances for product code DTX

  • K210669 — Quantum Mini Ventilation Module (May 4, 2021)
  • K202733 — Quantum Ventilation Module (October 16, 2020)
  • K181942 — Quantum Ventilation Module (October 18, 2018)
  • K101046 — STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM (December 9, 2010)
  • K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (January 17, 2003)
  • K965214 — COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002) (March 28, 1997)
  • K863902 — MODIFIED SARNS MEMBRANE OXYGENATOR (December 11, 1986)
  • K822820 — GAS-FLOW METER GFL 10 (October 18, 1982)
  • K790546 — FLOWMETER, OPTIFLO GAS (May 11, 1979)

FDA data resources