FDA-Device2017-01-18Class II

Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immedi

Stryker Sustainability Solutions
Hazard

A breach in the sterile packaging may have occurred resulting in potentially non-sterile product.

Sold states
U.S. distribution to the following: MI, TX, TN, IN, AL, FL, PA, AK, WI, MT, SC, CO, CA, NH, NC, NJ, DE, AZ, MN, MS, GA, DC, IA, NY, NM, KS, OH, OK, SD, OR, NV, VA, MD, WA, CT Foreign distribution to the following: CA.
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT, CR3434CT Ablation catheter cables are designed as electrode cables with a multi-pin connector on the distal end which connects to an ablation catheter and a multi-pin connector on the proximal end which connects to the appropriate equipment. The cables either interface an ablation catheter with the appropriate external radiofrequency generator or, serve as an extension cable between an ablation catheter and equipment out of immediate reach.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2017

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