FDA-Device2021-09-08Class II
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Cardiovascular Systems Inc
Hazard
There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Sold states
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Affected count
8 units
Manufactured in
1225 Old Highway 8 NW, N/A, Saint Paul, MN, United States
Products
DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2385-2021Don't want to check this manually?
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