FDA-Device2019-12-04Class II
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
Spectranetics Corporation
Hazard
The incorrect outer carton box was used for the product.
Sold states
Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution.
Affected count
3 catheters
Manufactured in
5055 Brandin Ct, Fremont, CA, United States
Products
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0576-2020Don't want to check this manually?
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