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510(k) K193664

SubQKath Catheter and Needle Set by Hk Surgical — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2020
Date Received
December 31, 2019
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 Hk Surgical

  • K123822 — KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET (September 27, 2013)
  • K032802 — HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III (November 19, 2003)
  • K031432 — KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II (August 7, 2003)

Other clearances for product code BSO

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  • 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)
  • 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)
  • K171193 — Certa Catheter (December 18, 2017)