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510(k) K130104

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

K130104 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "GUIDEWIRE, PURSUER SERIES". The FDA issued a decision of Substantially Equivalent on June 13, 2013. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Oscor, Inc. has at least 10 other 510(k) clearances on record.

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

  • K253667 — Accoat Guide Wire (July 14, 2026)
  • K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire (July 13, 2026)
  • K254137 — InQwire Amplatz Guide Wire (May 22, 2026)
  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 (March 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • 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)

FDA data resources