Home / 510(k) Clearances / K162723

510(k) K162723

TransFix/EDTA Vacuum Blood Collection Tubes by Caltag Medsystems, Ltd. — Product Code GIM

K162723 is an FDA 510(k) premarket notification submitted by Caltag Medsystems, Ltd. for the device "TransFix/EDTA Vacuum Blood Collection Tubes". The FDA issued a decision of Substantially Equivalent on June 22, 2017. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2017
Date Received
September 29, 2016
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 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)
  • K080552 — CYTO-CHEX BCT (July 31, 2008)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • 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