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510(k) K833294

ALPHA Y-RECIPIENT SET by Alpha Therapeutic Corp. — Product Code BRZ

K833294 is an FDA 510(k) premarket notification submitted by Alpha Therapeutic Corp. for the device "ALPHA Y-RECIPIENT SET". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Alpha Therapeutic Corp. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1983
Date Received
September 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Alpha Therapeutic Corp.

  • K970225 — ALPHA MICRON 20/40 MICROAGGREGATE FILTER (February 14, 1997)
  • K955515 — ALPHA MICRON 20 MICROAGGREGATE FILTER (February 12, 1996)
  • K854920 — THERAPY CASSETTS (May 19, 1986)
  • K854441 — STUART GILMAN'S WEIGHT LOSS PLAN (February 10, 1986)
  • K820447 — ALPHA PLASMA TRANSFER SET (April 14, 1982)
  • K810897 — ALPHA PLASTIC PLASMA BOTTLE (September 23, 1981)
  • K810761 — ALPHA MICRON-40 FILTER (June 30, 1981)

Other clearances for product code BRZ

  • K220558 — Blood Administration Sets (November 17, 2022)
  • K210335 — Blood Administration Set (June 10, 2021)
  • K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER (October 4, 2013)
  • K083349 — BLOOD TRANSFUSION SET (April 10, 2009)
  • K073339 — BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SI (March 3, 2008)
  • K041496 — PENTATRASFU BLOOD TRANSFUSION SETS (June 30, 2005)
  • K050805 — 30 ML OR 60 ML PEDI-SYRINGE FILTER (June 20, 2005)
  • K050115 — BLOOD HAND PUMP ADMINISTRATION SET (April 1, 2005)
  • K023039 — BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 (November 7, 2002)
  • K000685 — CHARTER MEDICAL NEONATAL SYRINGE SET (August 15, 2000)

FDA data resources