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510(k) K980098

VACUTAINER BRAND PRONTO NEEDLES HOLDER by Becton Dickinson Vacutainer Systems — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1998
Date Received
January 12, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Becton Dickinson Vacutainer Systems

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  • 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)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K960250 — VACUTAINER BRAND PLUS SERUM & SST TUBES (March 29, 1996)

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  • K243649 — BD Vacutainer® Multiple Sample Luer Adapter (March 21, 2025)
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