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510(k) K013304

BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER by Becton Dickinson Infusion Therapy Systems, Inc. — Product Code DBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2002
Date Received
October 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fab, Rhodamine, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5520
Review Panel
IM
Submission Type

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  • K250682 — BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed (June 3, 2025)
  • K241586 — PIVO™ Pro Needle-free Blood Collection Device (February 27, 2025)
  • K233529 — BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Con (December 1, 2023)
  • K230865 — PIVO™ Pro Needle-free Blood Collection Device (September 28, 2023)
  • K231239 — Nexiva™ Closed IV Catheter System with NearPort™ IV Access (September 22, 2023)
  • K220584 — BD Cathena Safety IV Catheter (March 31, 2022)

Other clearances for product code DBY

  • K022067 — CONVOY ADVANCED DELIVERY SHEATH (September 11, 2002)
  • K013919 — TORFLEX TRANSSEPTAL GUIDING SHEATH (February 22, 2002)
  • K013282 — GORE INTRODUCER SHEATH (December 14, 2001)
  • K013866 — CONVOY ADVANCED DELIVERY SHEATH KIT (December 14, 2001)
  • K771144 — RHODAMINE-CONJUGATED ANTISERUM (July 14, 1977)