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510(k) K140110

FLEXTIP PLUS EPIDURAL CATHETER;FLEXBLOCK CONTINOUS PERIPHERAL NERVE BLOCK CATHETER KIT/SET by Teleflex, Inc. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2015
Date Received
January 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

Other clearances by Teleflex, Inc.

  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • 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)
  • K860307 — PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET (May 20, 1986)

Other clearances for product code BSO

  • K241410 — EDEN ControlCath (February 13, 2025)
  • K231242 — Perifix FX Catheter; Contiplex FX Catheter (September 15, 2023)
  • K230603 — Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Nex (August 30, 2023)
  • K193664 — SubQKath Catheter and Needle Set (September 9, 2020)
  • K200624 — Percutaneous Introducer (April 27, 2020)
  • K191470 — C-CAT Anaesthesia Catheter kit (October 25, 2019)
  • K181782 — Medline Reinforced Epidural Catheter (March 4, 2019)
  • K173541 — EPINAUT (August 24, 2018)
  • K172777 — Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 (May 3, 2018)
  • K171584 — B. Braun Tear-Away Introducer Needle (December 22, 2017)