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510(k) K991259

TE ME NA EPIDURAL CATHETER by Te ME NA S.A.R.L. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2001
Date Received
April 13, 1999
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 Te ME NA S.A.R.L.

  • K990323 — TE ME NA POLYSTIM NERVE STIMILATOR (September 28, 2001)
  • K002405 — SPINAL EPIDURAL NEEDLES (June 1, 2001)
  • K990100 — POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE (August 2, 2000)
  • K990020 — TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC (June 24, 1999)

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)