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510(k) K894794

AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP by Vitaid, Ltd. — Product Code KPM

K894794 is an FDA 510(k) premarket notification submitted by Vitaid, Ltd. for the device "AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP". The FDA issued a decision of Substantially Equivalent on November 21, 1989. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Vitaid, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1989
Date Received
July 28, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Peritoneal
Device Class
Class II
Regulation Number
876.5955
Review Panel
GU
Submission Type

Other clearances by Vitaid, Ltd.

  • K050803 — PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES (June 30, 2005)
  • K932647 — WIRE REINFORCED ENDOTRACHEAL TUBE (November 2, 1993)
  • K901738 — SELFCATH (June 27, 1990)
  • K894883 — PHYCON ALL SILICONE BALLOON CATHETER (April 25, 1990)
  • K894669 — LASER SHIELDING TUBE (October 13, 1989)
  • K894337 — UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM (September 29, 1989)

Other clearances for product code KPM

  • K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System (August 18, 2023)
  • K170405 — BD Curve Ascites Shunt (November 2, 2017)
  • K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PU (October 4, 2001)
  • K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (July 12, 2001)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (June 1, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHU (January 2, 2001)
  • K973129 — DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (March 17, 1998)
  • K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (April 14, 1997)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (February 18, 1994)
  • K901360 — LEVEEN PERITINEO-VENOUS SHUNT (August 21, 1990)

FDA data resources