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510(k) K971449

VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) by Becton Dickinson Vacutainer Systems — Product Code GIM

K971449 is an FDA 510(k) premarket notification submitted by Becton Dickinson Vacutainer Systems for the device "VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)". The FDA issued a decision of Substantially Equivalent on June 17, 1997. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Becton Dickinson Vacutainer Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1997
Date Received
April 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Becton Dickinson Vacutainer Systems

  • K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (November 2, 2000)
  • K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, (July 28, 1999)
  • K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY- (May 28, 1999)
  • K991120 — VACUTAINER BRAND CTAD TUBE (MULTIPLE) (May 19, 1999)
  • K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608 (October 28, 1998)
  • K982922 — VACUTAINER BRAND BLOOD COLLECTION SYRINGE (September 22, 1998)
  • K981013 — VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE (June 17, 1998)
  • K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (February 24, 1998)
  • K980098 — VACUTAINER BRAND PRONTO NEEDLES HOLDER (February 5, 1998)
  • K960250 — VACUTAINER BRAND PLUS SERUM & SST TUBES (March 29, 1996)

Other clearances for product code GIM

  • K240455 — BD Vacutainer® Citrate Blood Collection Tubes (October 31, 2024)
  • K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blo (November 27, 2023)
  • K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collecti (August 25, 2023)
  • K162723 — TransFix/EDTA Vacuum Blood Collection Tubes (June 22, 2017)
  • K080552 — CYTO-CHEX BCT (July 31, 2008)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K971221 — GREINER VACUETTE BLOOD COLLECTION TUBE (May 2, 1997)
  • K951886 — LOK-ON NEEDLE DISPOSAL SYSTEM (June 30, 1995)
  • K945458 — VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (February 6, 1995)
  • K944814 — CORVAC PLASTIC BLOOD COLLECTION TUBE (December 19, 1994)

FDA data resources