REPROCESSED VASCULAR DEVICES Product Description: EP cables are sterile extension cables that provide a conduit/connection between each diagnostic or ablation catheter and the corresponding equipment console. Program Overview: Stryker has FDA 510(k) clearance to reprocess single-use cables and validated cycles for reusable diagnostic and ablation cables, including Carto ® 3 cables. Stryker’s comprehensive EP cable reprocessing program includes: • Validated device-specific cleaning processes • Electrical performance testing • Additional high-voltage safety performance testing (ablation cables) • Individual device packaging and labeling • Ethylene oxide sterilization • Complete device tracking and management • Up to 60% cost savings as compared with original pricing Sterile extension cables for use with: Diagnostic EP Catheters Ablation Catheters Carto® 3 Systems Product Summary: EP CABLES SINGLE-USE & REUSABLE DIAGNOSTIC/ABLATION
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Transcript
R E P R O C E S S E D V A S C U L A R D E V I C E S
Product Description: EP cables are sterile extension cables that provide
a conduit/connection between each diagnostic or ablation catheter and the
corresponding equipment console.
Program Overview: Stryker has FDA 510(k) clearance to reprocess single-use
cables and validated cycles for reusable diagnostic and ablation cables,
including Carto® 3 cables. Stryker’s comprehensive EP cable reprocessing