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510(k) K854562

CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I by Medelec Intl. Corp. — Product Code BRZ

K854562 is an FDA 510(k) premarket notification submitted by Medelec Intl. Corp. for the device "CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I". The FDA issued a decision of Substantially Equivalent on January 9, 1986. The device falls under product code BRZ (Set, Blood Transfusion), a Class II device regulated under 21 CFR 880.5440. Medelec Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1986
Date Received
November 14, 1985
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 Medelec Intl. Corp.

  • K961013 — DISPOSABLE NEEDLE ELECTRODE (December 20, 1996)
  • K935017 — TD50 ELECTROMYOGRAPH (July 28, 1994)
  • K922548 — MEDELEC 2110 AND 2114 EEG (November 3, 1992)
  • K920127 — ELECTROENCEPHALOGRAPH RECORDING SYSTEM (June 10, 1992)
  • K912775 — SAPPHIRE 4ME EMG/EP SYSTEM (November 8, 1991)
  • K865106 — PROPHYLACTIC (CONDOM) MR. JOHNNY (May 20, 1987)
  • K863491 — BLOOD SPECIMEN COLLECTION DEVICES (October 24, 1986)
  • K854622 — PROPHYLACTIC (CONDOM) (April 11, 1986)
  • K854860 — BLADES, SCALPEL CARBON STEET (December 24, 1985)
  • K854859 — BLADES, SCALPEL STAINLESS STEEL (December 24, 1985)

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