Cleared Traditional

GUIDEWIRE, PURSUER SERIES

K130104 · Oscor, Inc. · Cardiovascular
Jun 2013
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K130104 is an FDA 510(k) clearance for the GUIDEWIRE, PURSUER SERIES, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on June 13, 2013, 149 days after receiving the submission on January 15, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number K130104 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2013
Decision Date June 13, 2013
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DQX — Wire, Guide, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1330

Similar Devices — DQX Wire, Guide, Catheter

All 760
EmeryGlide? (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026
Lunderquist Extra Stiff Wire Guide
K251596 · William Cook Europe Aps · Nov 2025
SureAx-Guide?
K250203 · Sureax Medical, LLC · Oct 2025