Home / 510(k) Clearances / K121403

510(k) K121403

CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET by Teleflex, Inc. — Product Code CAZ

K121403 is an FDA 510(k) premarket notification submitted by Teleflex, Inc. for the device "CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET". The FDA issued a decision of Substantially Equivalent on June 20, 2012. The device falls under product code CAZ (Anesthesia Conduction Kit), a Class II device regulated under 21 CFR 868.5140. Teleflex, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2012
Date Received
May 10, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anesthesia Conduction Kit
Device Class
Class II
Regulation Number
868.5140
Review Panel
AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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)
  • 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 CAZ

  • K222341 — Arrow 0.2 Micron Flat Filter, GVS (February 13, 2023)
  • K210983 — BD Epilor Syringe (May 19, 2022)
  • K201356 — Plastic LOR Syringe (February 12, 2021)
  • K202699 — E-Cath STIM acc. Tsui (December 29, 2020)
  • K190345 — VPC (May 16, 2019)
  • K161075 — Arrow Epidural Catheter Kit (October 4, 2016)
  • K153652 — ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set (June 21, 2016)
  • K143581 — Arrow Epidural Catheter Kit (June 26, 2015)
  • K122690 — ULTRAQUIK PERIPHERAL NERVE BLOCK NEEDLE (December 21, 2012)
  • K110053 — CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRIN (September 14, 2012)

FDA data resources