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FDA-Device2026-04-08Class II

Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA

SUMMA THERAPEUTICS, LLC
Hazard
Potential for the balloon in the device to not meet burst specifications.
Sold states
US Nationwide distribution in the states of New Jersey, Florida.
Affected count
22 units
Manufactured in
119 Braintree St Ste 508, Allston, MA, United States
Products
Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1704-2026

Original summary

Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA Potential for the balloon in the device to not meet burst specifications. Model/Catalog Number: FS252251502; UDI-DI: 00810017490967; lots: 240502, 240095, 231296, 231296A and 240095A; Distribution: US Nationwide distribution in the states of New Jersey, Florida. Affected quantity: 22 units

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