Home / 510(k) Clearances / K943127

510(k) K943127

PHARMASSURE LARGE VOLUME TRANSFER FILTERS by Gelman Sciences, Inc. — Product Code FPB

K943127 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "PHARMASSURE LARGE VOLUME TRANSFER FILTERS". The FDA issued a decision of Substantially Equivalent on September 29, 1994. The device falls under product code FPB (Filter, Infusion Line), a Class II device regulated under 21 CFR 880.5440. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1994
Date Received
June 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Infusion Line
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (March 17, 1995)
  • K941589 — SYRINGE FILTER DEVICES (September 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (August 10, 1994)
  • K942275 — VIAL VENT FILTER (July 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K884178 — DRUG CONTROL SET (February 17, 1989)
  • K884177 — DRUG STANDARD SET (February 17, 1989)

Other clearances for product code FPB

  • K233277 — Filter Needle for Single Use (May 10, 2024)
  • K143583 — Cathivex ¿GV filter units (August 11, 2015)
  • K113227 — NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (December 8, 2011)
  • K021293 — ARTERIA BLOOD FILTER (August 22, 2002)
  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K974661 — 0.2 U BACTERIAL FILTER (February 11, 1998)
  • K964283 — AUTOPRIME (January 22, 1997)
  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K933523 — I.V. FILTER SET (May 19, 1995)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)

FDA data resources