FDA-Device2014-06-25Class II
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Boston Scientific Corporation
Hazard
Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according to specification.
Sold states
Nationwide Distribution.
Affected count
968 units - all models
Manufactured in
47215 Lakeview Blvd, N/A, Fremont, CA, United States
Products
IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetric Curve. The BSC Controller and Accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1799-2014Don't want to check this manually?
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