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510(k) K003451

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T by Denver Biomedicals, Inc. — Product Code KPM

K003451 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T". The FDA issued a decision of Substantially Equivalent on January 2, 2001. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Denver Biomedicals, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2001
Date Received
November 7, 2000
Clearance Type
Special
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 Denver Biomedicals, Inc.

  • K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (June 13, 2005)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (June 1, 2001)
  • K010642 — PLEURX PLEURAL CATHETER AND DRAINAGE KITS (March 20, 2001)
  • K943968 — TUNNELER (March 1, 1995)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (February 18, 1994)
  • K842139 — THE DENVER PLEURAL-PERITONEAL SHUNT (August 27, 1984)
  • K822686 — DENVER PERITONEO-VENOUS SHUNT (DP-VS) (September 21, 1982)
  • K811577 — CROUCH CORNEAL PROTECTOR (August 7, 1981)
  • K811183 — DENVER PERITONEO-VENOUS SHUNT (July 1, 1981)

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)
  • 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)
  • K894794 — AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP (November 21, 1989)

FDA data resources