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510(k) K792185

PIASMA SAFE by Cry-O-Safe, Inc. — Product Code KSR

K792185 is an FDA 510(k) premarket notification submitted by Cry-O-Safe, Inc. for the device "PIASMA SAFE". The FDA issued a decision of Substantially Equivalent on December 28, 1979. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1979
Date Received
October 31, 1979
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 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)
  • K811449 — HAEMONETICS 1000ML COMPONENT BAG (July 1, 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)

FDA data resources