Endovascular Guide Wire

• 6 recalls, same reason

  • Terminated Z-0593-04 FDA Unclassified (pre-2012) ·initiated 27 Jan 2004 ·on shared 510(k) K021363
  • Terminated Z-0595-04 FDA Unclassified (pre-2012) ·initiated 27 Jan 2004 ·on shared 510(k) K021363
  • Terminated Z-0594-04 FDA Unclassified (pre-2012) ·initiated 27 Jan 2004 ·on shared 510(k) K021363
  • Terminated Z-0590-04 FDA Unclassified (pre-2012) ·initiated 27 Jan 2004 ·on shared 510(k) K021363
  • Terminated Z-0591-04 FDA Unclassified (pre-2012) ·initiated 27 Jan 2004 ·on shared 510(k) K021363
  • Terminated Z-0592-04 FDA Unclassified (pre-2012) ·initiated 27 Jan 2004 ·on shared 510(k) K021363

  The magnet at the end of the guidewire could break off.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1. 27 Nov 2002 Cleared FDA 510(k) K021363
2. 27 Jan 2004 Recall initiated FDA recalls Z-0593-04
3. 27 Jan 2004 Recall initiated FDA recalls Z-0595-04
4. 27 Jan 2004 Recall initiated FDA recalls Z-0594-04
5. 27 Jan 2004 Recall initiated FDA recalls Z-0590-04
6. 27 Jan 2004 Recall initiated FDA recalls Z-0591-04
7. 27 Jan 2004 Recall initiated FDA recalls Z-0592-04

510(k) Number

K021363 ↗

FDA product code

DQX

Device class

Class II

Regulation

21 CFR Part 870.1330

Advisory committee

Cardiovascular

FDA decision

SESE Substantially Equivalent

Other devices filed under FDA product code DQX (Wire, Guide, Catheter).

• MANDREL GUIDEWIRES OR M-WIRES by Lake Region Mfg., Inc.
• WireClip Torquer by Boston Scientific Corporation Northwest Technology
• SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI by Schneider Intl., Ltd.
• ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE by Advanced Cardiovascular Systems, Inc.
• RADIUS COUGAR WIRE by Radius Medical Technologies, Inc.
• Roadrunner UniGlide G56148 HPW-35-80 by COOK INCORPORATED
• ASAHI PTCA Guide Wire ASAHI Gaia Next by ASAHI INTECC CO., LTD.
• Guidewire SGW-035-07 by GALT MEDICAL CORP.
• LAKE REGION VARIABLE STIFFNESS GUIDEWIRE (VSGW) by Lake Region Mfg., Inc.
• HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH by Abbott Vascular-Cardiac Therapies

• Niobe MNS Omega ES Omega

  Class II

  FDA 510(k) K192775 Active Cleared 30 Oct 2019 GUDID on market

• GenesisX 1

  Class II

  FDA 510(k) K251792 Active Cleared 6 Nov 2025 GUDID on market

• GenesisX RMN

  Class II

  FDA 510(k) K262744 Active Cleared 27 Aug 2026

• Navigant

  Class IIb

  CE/MDR GUDID on market

See all devices from Stereotaxis, Inc. →