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510(k) K935236

FLOW CONTROLLING EXTENSION SET by Block Medical, Inc. — Product Code LDR

K935236 is an FDA 510(k) premarket notification submitted by Block Medical, Inc. for the device "FLOW CONTROLLING EXTENSION SET". The FDA issued a decision of Substantially Equivalent on February 24, 1994. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. Block Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1994
Date Received
November 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Infusion, Intravascular, Electronic
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

Other clearances by Block Medical, Inc.

  • K944692 — C-SERIES HOMEPUMP (May 2, 1995)
  • K940117 — MID-500 (June 10, 1994)
  • K934551 — VERIFUSE AMBULATORY PUMP (March 17, 1994)
  • K932740 — HOMEPUMP NSF (October 6, 1993)
  • K904663 — AUTO SASH (TM) (November 23, 1992)
  • K914924 — CHEMO PRIMING PIN(TM) (March 6, 1992)
  • K914854 — THUMPER (January 24, 1992)
  • K914855 — MULTIPLE DOSE CONTROLLER (January 24, 1992)
  • K910695 — AUTO SASH (TM) (March 21, 1991)
  • K902891 — VERIFUSE AMBULATORY PUMP (November 21, 1990)

Other clearances for product code LDR

  • K242693 — DEKA Infusion System, DEKA Administration Set (October 7, 2024)
  • K232316 — DEKA Infusion System, DEKA Administration Set (March 1, 2024)
  • K153760 — Volumetric Infusion Controller (October 3, 2016)
  • K963136 — PACER MODEL 100 INFUSION CONTROLLER (October 10, 1997)
  • K971865 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (July 3, 1997)
  • K971826 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (July 3, 1997)
  • K934543 — UNIVERSAL CONTROLLER, MODEL 100 (March 29, 1994)
  • K905498 — STAT 2 IV PUMPETTE (April 16, 1991)
  • K905497 — MASTER FLOW I.V. PUMPETTE (April 16, 1991)
  • K896907 — 3M IV FLOW REGULATOR (February 26, 1990)

FDA data resources