Lumend Percutaneous Catheter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K011562 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Outback Catheter

  Class II

  FDA 510(k) K040771 Active Cleared 23 Apr 2004

• Modification to Lumend Frontrunner Cto Catheter

  Class II

  FDA 510(k) K023223 Active Cleared 24 Oct 2002

• Lumend Frontrunner Cto Coronary Catheter

  Class II

  FDA 510(k) K013284 Active Cleared 11 Feb 2002

• Outback Catheter

  Class II

  FDA 510(k) K032298 Active Cleared 26 Aug 2003

• Lumend Frontrunner Cto Catheter

  Class II

  FDA 510(k) K023114 Active Cleared 23 Jan 2003

• Frontrunner CTO Catheter and Accessories

  Class II

  FDA 510(k) K033535 Active Cleared 7 Jan 2004

See all devices from Lumend, Inc. →

• What clinical purpose does the Lumend Percutaneous Catheter serve?

  It is designed to be used with a steerable guide wire to reach specific areas of the coronary vasculature, offering guide‑wire support and catheter guidance comparable to standard coronary catheters employed in percutaneous interventions.

• How was the Lumend Percutaneous Catheter cleared for market use?

  The device received traditional FDA 510(k) clearance on 16 January 2002, with decision code SESE and product code DQY, classifying it as a Class 2 cardiovascular device under the traditional clearance pathway.

• Which advisory committee reviewed the Lumend Percutaneous Catheter submission?

  The submission was reviewed by the Cardiovascular (CV) advisory committee, as indicated by the advisory committee description and review advisory committee fields in the clearance documentation.

• Who manufactures the Lumend Percutaneous Catheter and where is it produced?

  Lumend, Inc. manufactures the catheter at its facility located at 400 Chesapeake Dr., Redwood City, California, United States, zip code 94063.