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510(k) K860307

PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET by Teleflex, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
January 28, 1986
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)
  • K123974 — PERCUTANEOUS INTRODUCER KIT (February 21, 2013)
  • 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)

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  • 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)