FDA-Device2017-08-09Class II
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible c
Greatbatch Medical
Hazard
One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Sold states
CA
Affected count
11,360
Manufactured in
2300 Berkshire Ln N, N/A, Plymouth, MN, United States
Products
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2782-2017Don't want to check this manually?
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