FDA-Device2021-08-18Class II
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Merit Medical Systems, Inc.
Hazard
There is a potential that 7F sheaths are packaged as 10F sheaths.
Sold states
US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway
Affected count
760 units
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2238-2021Don't want to check this manually?
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