Home / 510(k) Clearances / K940055

510(k) K940055

MULTISET by Puritas Health Care, Inc. — Product Code BRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
January 5, 1994
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 Puritas Health Care, Inc.

  • K942339 — SKIN NEUVEAU SCAR TREATMENT (November 28, 1994)
  • K941197 — SILK*SKIN SCAR TREATMENT (August 11, 1994)
  • K935600 — TRACHEAL SUCTION CATHETER (May 10, 1994)
  • K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (May 5, 1994)
  • K940074 — Y-TYPE BLOOD ADMINISTRATION SET (April 21, 1994)
  • K940054 — MEASURED VOLUME SOLUTION ADMINISTRATION SET (April 15, 1994)
  • K935583 — SUCTION SET, TRACHAEL (April 11, 1994)
  • K940056 — WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM (April 4, 1994)
  • K935532 — TRANSFER SET (April 4, 1994)
  • K940070 — STOPCOCK INTRAVENOUS THERAPY (April 4, 1994)

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)