Home / 510(k) Clearances / K151936

510(k) K151936

Steerable Intracardiac Catheter Introducer Kit and Transseptal Needle by Synaptic Medical Limited — Product Code DYB

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 4, 2015
Date Received
July 14, 2015
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 Synaptic Medical Limited

  • K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (August 29, 2014)
  • K133028 — RITHM ID ELECTROPHYSIOLOGY CATHETER (March 4, 2014)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • 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)