Home / 510(k) Clearances / K934551

510(k) K934551

VERIFUSE AMBULATORY PUMP by Block Medical, Inc. — Product Code MEA

K934551 is an FDA 510(k) premarket notification submitted by Block Medical, Inc. for the device "VERIFUSE AMBULATORY PUMP". The FDA issued a decision of Substantially Equivalent on March 17, 1994. The device falls under product code MEA (Pump, Infusion, Pca), 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
March 17, 1994
Date Received
September 22, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Pca
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)
  • K935236 — FLOW CONTROLLING EXTENSION SET (February 24, 1994)
  • K932740 — HOMEPUMP NSF (October 6, 1993)
  • K904663 — AUTO SASH (TM) (November 23, 1992)
  • K914924 — CHEMO PRIMING PIN(TM) (March 6, 1992)
  • K914855 — MULTIPLE DOSE CONTROLLER (January 24, 1992)
  • K914854 — THUMPER (January 24, 1992)
  • K910695 — AUTO SASH (TM) (March 21, 1991)
  • K902891 — VERIFUSE AMBULATORY PUMP (November 21, 1990)

Other clearances for product code MEA

  • K162165 — ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Inte (August 29, 2017)
  • K170982 — CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis I (August 24, 2017)
  • K143612 — LifeCare PCA Infusion System (April 8, 2016)
  • K130394 — CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 (December 9, 2013)
  • K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM (November 4, 2009)
  • K072144 — CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE (March 7, 2008)
  • K051253 — MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR (July 15, 2005)
  • K043299 — MEDLEY PCA MODULE, MODEL 8120 (December 10, 2004)
  • K043256 — HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTE (December 6, 2004)
  • K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE (October 18, 2004)

FDA data resources