Home / 510(k) Clearances / K123974

510(k) K123974

PERCUTANEOUS INTRODUCER KIT by Teleflex, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2013
Date Received
December 26, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Teleflex, Inc.

  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K140110 — FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHET (March 27, 2015)
  • K141940 — CONCHASMART COLUMN (November 24, 2014)
  • K140556 — CONCHASMART BREATHING CIRCUIT (September 24, 2014)
  • K131912 — CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHA (March 6, 2014)
  • K121403 — CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET (June 20, 2012)
  • K103658 — FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER (May 16, 2012)
  • K861951 — MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER (June 19, 1986)
  • K860307 — PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET (May 20, 1986)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)