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510(k) K872895

HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS. by Haemonetics Corp. — Product Code CAL

K872895 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.". The FDA issued a decision of Substantially Equivalent on January 11, 1988. The device falls under product code CAL (Laryngoscope, Non-Rigid), a Class I device regulated under 21 CFR 868.5530. Haemonetics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1988
Date Received
July 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laryngoscope, Non-Rigid
Device Class
Class I
Regulation Number
868.5530
Review Panel
AN
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 CAL

  • K951195 — FI-10P (April 6, 1995)
  • K951194 — FI-10M (April 6, 1995)
  • K852994 — REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11 (July 29, 1985)
  • K850978 — OLYMPUS LF-1 INTUBATION SCOPE (May 23, 1985)
  • K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-7 (October 10, 1980)
  • K801364 — AO STYLET LARYNGOSCOPE MODEL SLS (June 17, 1980)
  • K791634 — AO STYLET LARYNGOSCOPE, MODEL SLS-1 (September 17, 1979)

FDA data resources