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510(k) K811449

HAEMONETICS 1000ML COMPONENT BAG by Haemonetics Corp. — Product Code KSR

K811449 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "HAEMONETICS 1000ML COMPONENT BAG". The FDA issued a decision of Substantially Equivalent on July 1, 1981. The device falls under product code KSR (Container, Empty, For Collection & Processing Of Blood & Blood Components), a Class II device regulated under 21 CFR 864.9100. Haemonetics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1981
Date Received
May 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class
Class II
Regulation Number
864.9100
Review Panel
HE
Submission Type

Other clearances by Haemonetics Corp.

  • K251024 — TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (April 30, 2025)
  • K122262 — ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEM (October 25, 2012)
  • K120586 — CELL SAVER ELITE (May 22, 2012)
  • K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM (December 3, 2010)
  • K062801 — SMARTSUCTION SOLO DEVICE (October 4, 2006)
  • K061103 — HAEMONETICS 40U RBC FILTER BAG (May 17, 2006)
  • K053000 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (November 21, 2005)
  • K052626 — SMARTSUCTION HARMONY DEVICE (October 5, 2005)
  • K043127 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (January 4, 2005)
  • K014083 — HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM (January 8, 2002)

Other clearances for product code KSR

  • K032827 — KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501 (December 8, 2003)
  • K020753 — DEROYAL SURGICAL, UMBILICUP (June 13, 2002)
  • K810500 — BLOOD FREEZING BAG (September 23, 1981)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K811523 — PLASMA FLEX (September 9, 1981)
  • K810711 — HAEMONETICS 600 ML. COMPONENT BAG (May 8, 1981)
  • K810313 — HAEMONETICS 1400 ML THERAPEUTIC BAG (March 31, 1981)
  • K801082 — GAMBRO HEMOFREEZE-BAG (October 31, 1980)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K792395 — PHARMAFLEX CRYOGENIC BAG (February 26, 1980)

FDA data resources