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510(k) K822686

DENVER PERITONEO-VENOUS SHUNT (DP-VS) by Denver Biomedicals, Inc. — Product Code KPM

K822686 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "DENVER PERITONEO-VENOUS SHUNT (DP-VS)". The FDA issued a decision of Substantially Equivalent on Sep 21, 1982. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Denver Biomedicals, Inc. has 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 21, 1982
Date Received
Sep 3, 1982
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
510(k)

Other clearances by Denver Biomedicals, Inc.

  • K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (Jun 13, 2005)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (Jun 1, 2001)
  • K010642 — PLEURX PLEURAL CATHETER AND DRAINAGE KITS (Mar 20, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES… (Jan 2, 2001)
  • K943968 — TUNNELER (Mar 1, 1995)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (Feb 18, 1994)
  • K842139 — THE DENVER PLEURAL-PERITONEAL SHUNT (Aug 27, 1984)
  • K811577 — CROUCH CORNEAL PROTECTOR (Aug 7, 1981)
  • K811183 — DENVER PERITONEO-VENOUS SHUNT (Jul 1, 1981)

Other clearances for product code KPM

  • K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System (Aug 18, 2023)
  • K170405 — BD Curve Ascites Shunt (Nov 2, 2017)
  • K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL… (Oct 4, 2001)
  • K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (Jul 12, 2001)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (Jun 1, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES… (Jan 2, 2001)
  • K973129 — DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (Mar 17, 1998)
  • K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (Apr 14, 1997)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (Feb 18, 1994)
  • K901360 — LEVEEN PERITINEO-VENOUS SHUNT (Aug 21, 1990)

FDA data resources