Home / 510(k) Clearances / K082580

510(k) K082580

SPECTRA GUIDEWIRE INTRODUCER NEEDLE by Spectra Medical Devices, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2008
Date Received
September 5, 2008
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 Spectra Medical Devices, Inc.

  • K163292 — Sonic Block Tuohy, Sonic Block Quincke, Sonic Block Chiba, Sonic Block Crawford (September 8, 2017)
  • K151069 — SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle (February 5, 2016)
  • K142791 — Spectra Soft Tissue Biopsy Needles (January 21, 2015)
  • K103740 — SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE (July 29, 2011)
  • K082689 — STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE (March 20, 2009)
  • K082674 — SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA (November 28, 2008)
  • K081524 — SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PL (July 29, 2008)

Other clearances for product code DYB

  • K261492 — FieldFlex Steerable Sheath (June 5, 2026)
  • K260606 — Echo Large Bore Introducer Sheath (April 29, 2026)
  • K254248 — Introducer Sheath Set (April 23, 2026)
  • K254279 — Edwards eSheath+ introducer set (April 17, 2026)
  • K260091 — Aventus Introducer Sheath (April 13, 2026)
  • K260839 — Protaryx Transseptal Puncture Device (PTX2-001) (April 10, 2026)
  • K260942 — AuST Steerable Sheath (April 7, 2026)
  • K260459 — VANES Delivery System (VDS) (April 6, 2026)
  • K260626 — Multiflex Steerable Sheath 17.5F (March 26, 2026)
  • K260163 — AuST CSP Introducer (February 19, 2026)