Home / 510(k) Clearances / K854259

510(k) K854259

SEPACELL R-500 & SEPACELL R-500A by Advocacy International, Ltd. — Product Code CAK

K854259 is an FDA 510(k) premarket notification submitted by Advocacy International, Ltd. for the device "SEPACELL R-500 & SEPACELL R-500A". The FDA issued a decision of Substantially Equivalent on January 8, 1986. The device falls under product code CAK (Microfilter, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Advocacy International, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1986
Date Received
October 23, 1985
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 Advocacy International, Ltd.

  • K874027 — LIPASE UV [TOYO] (May 27, 1988)
  • K873792 — SEPACELL R-500 AND SEPACELL R-500A (January 19, 1988)
  • K855251 — MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS (February 4, 1986)
  • K855212 — ASAHI AM SERIES DIALYZERS (January 21, 1986)
  • K842103 — TOYO JOZO URIC ACID TEST (August 12, 1984)
  • K842104 — TOYO JOZO G-GTP TEST (August 10, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)
  • K813037 — FLOWGUARD CATHETERS & CANNALAE (December 14, 1981)

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)
  • K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST) (April 22, 1996)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K904221 — SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS (October 26, 1990)

FDA data resources