Terumo Medical Corporation

Lot: VK09, Expiration Date: 31-Jan-2020

Cardiovascular Devices

2

No

To be added.

Destination Guiding Sheath catheter introducer, Catalog Number: RSR06 || Product Usage: || The Destination¿ Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal, carotid, and peripheral arteries.

RSC01

Cardiovascular Devices

2

No

Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama

Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 || Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

Lot MP08

Cardiovascular Devices

2

No

Nationwide Distribution.

Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. || Used to facilitate placing a catheter through the skin into a vein or artery.

Lot MM27

Cardiovascular Devices

2

No

Nationwide Distribution.

Pinnacle¿ Destination¿ Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. || Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature.

Lot 101028, exp 2013 - 09

Cardiovascular Devices

2

No

Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.

Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH || Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)