CRIMPER

Injections / Infusions / Transfusions / Dialysis - catheters

Models 9100CR23, all lot numbers.

Cardiovascular Devices

3

Yes

Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.

Edwards Lifesciences Crimpers, Model 9100CR23. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

Models 9100CR26, all lot numbers.

Cardiovascular Devices

3

Yes

Nationwide Distribution-USA (nationwide) including DC and the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI.

Edwards Lifesciences Crimpers, Model 9100CR26. || The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.

lot 59617777 and 59658495.

Cardiovascular Devices

3

Yes

Nationwide Distribution

Crimper Model 9100CR26 || The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.

9100CR, 9340CR

MD: Basic crimper