K-number	K220171
Device name	NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
Applicant	Northeast Scientific, Inc.
Product code	QTF
Device class	Class II
Decision date	Jul 1, 2022
Decision	Substantially Equivalent
Regulation	870.4875

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Source

View the full FDA submission: accessdata.fda.gov

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NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

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