510(k) for Spectranetics' laser sheaths:
This article was originally published in Clinica
Executive Summary
The FDA has cleared Spectranetics' 14 and 16 French laser sheaths for removing larger pacemaker and implantable cardioverter defibrillator leads. With this 510(k) approval, the Colorado, Colorado-based company's entire laser sheath product line will now be available to all hospitals.