Home / 510(k) Clearances / K130104

510(k) K130104

GUIDEWIRE, PURSUER SERIES by Oscor, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2013
Date Received
January 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Oscor, Inc.

  • K210627 — Breezeway II (June 3, 2021)
  • K151951 — Destino Reach (September 22, 2015)
  • K143463 — IS4/DF4 Port Plug (March 19, 2015)
  • K140917 — INTRODUCER, MODEL ADELANTE MAGNUM (July 9, 2014)
  • K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH (April 17, 2014)
  • K130633 — INTRODUCER SETS, MODEL ADELANTE RADIAL (February 13, 2014)
  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)
  • K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (December 13, 2012)
  • K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (December 13, 2012)
  • K122084 — INTRODUCER SET, MODEL ADELANTE-S SERIES (August 29, 2012)

Other clearances for product code DQX

  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)