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510(k) K770602

VALVE, ASCITES, LAVEEN by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code KPM

K770602 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "VALVE, ASCITES, LAVEEN". The FDA issued a decision of Substantially Equivalent on Apr 15, 1977. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Bd Becton Dickinson Vacutainer Systems Preanalytic has 631 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 15, 1977
Date Received
Mar 30, 1977
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 Bd Becton Dickinson Vacutainer Systems Preanalytic

  • K003062 — BACTEC MGIT 960 SIR KITS (Jun 6, 2001)
  • K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE (Mar 21, 2001)
  • K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE (Feb 1, 2001)
  • K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/16 (Nov 29, 2000)
  • K001364 — BD DIRECTIGEN FLU A+B (Jun 28, 2000)
  • K000762 — MOXIFLOXACIN, 5 UG, BBL SENSI-DISC (Apr 25, 2000)
  • K000829 — GATIFLOXACIN, 5 UG, BBL SENSI-DISC (Apr 13, 2000)
  • K993186 — SYNERCID, 15 UG, BBL SENSI-DISC (Nov 3, 1999)
  • K992734 — BECTON DICKINSON SYRINGE (Oct 1, 1999)
  • K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM (Sep 23, 1999)

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