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510(k) K960486

KSEA MODEL 383320 20 ANGIOMAT by Karl Storz Endoscopy — Product Code DQI

K960486 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "KSEA MODEL 383320 20 ANGIOMAT". The FDA issued a decision of Substantially Equivalent on October 25, 1996. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1996
Date Received
February 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type

Other clearances by Karl Storz Endoscopy

  • K043375 — FISCH TITANIUM MIDDLE EAR PROSTHESES (January 24, 2005)
  • K030848 — PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (June 2, 2003)
  • K030009 — KSEA POWERSHAVER SYSTEM S2 (April 2, 2003)
  • K023924 — AUTOCON II 200 ELECTROSURGICAL GENERATOR (February 21, 2003)
  • K023187 — KSEA SPINOSCOPE (December 2, 2002)
  • K011700 — MODULITH SLK LITHOTRIPTER (August 16, 2002)
  • K021776 — KSEA QUADRO SWITCH (August 15, 2002)
  • K013107 — BIOABSORBABLE INTERFERENCE SCREW MEGAFIX (February 26, 2002)
  • K011841 — KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR (September 10, 2001)
  • K010569 — KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP (April 9, 2001)

Other clearances for product code DQI

  • K935763 — SURGIPUMP (April 21, 1994)
  • K922541 — USCI SUPER 9 PTCA GUIDING CATHETER (December 8, 1992)
  • K924110 — LEOCOR CORFLO PUMP -- MODIFICATION (September 1, 1992)
  • K905189 — BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (January 30, 1991)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K895688 — NOBLES-LAI ENGINEERING INFUSION PUMP (February 26, 1990)
  • K895074 — ANGIOSCOPY PUMP (January 31, 1990)
  • K871422 — OLYMPUS ANGIOSCOPY PUMP (August 12, 1987)

FDA data resources