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510(k) K960993

PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) by Pall Biomedical Products Co. — Product Code CAK

K960993 is an FDA 510(k) premarket notification submitted by Pall Biomedical Products Co. for the device "PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)". The FDA issued a decision of Substantially Equivalent on April 22, 1996. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Pall Biomedical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1996
Date Received
March 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Pall Biomedical Products Co.

  • K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (January 9, 1997)
  • K905794 — PALL 3N1 FILTER (June 13, 1991)
  • K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE (October 16, 1990)
  • K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER (January 24, 1989)
  • K875095 — PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K873666 — PALL LEUKOCYTE REMOVAL FILTER, BLOOD (January 6, 1988)
  • K873667 — PALL LEUKOCYTE REMOVAL FILTER, PLATELETS (January 6, 1988)
  • K874405 — PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE (December 30, 1987)
  • K853987 — PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE (December 11, 1985)

Other clearances for product code CAK

  • K061103 — HAEMONETICS 40U RBC FILTER BAG (May 17, 2006)
  • K022477 — SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUS (October 25, 2002)
  • K000719 — NEOCARE 20 MICRON BLOOD FILTER (May 30, 2000)
  • K990310 — CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (August 30, 1999)
  • K982822 — FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PED (September 30, 1998)
  • K972159 — FENWAL 40 MICRON TRANSFUSION FILTER (July 23, 1997)
  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)
  • K904223 — SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS (October 26, 1990)

FDA data resources