Name: Predicase
Price: 199 USD

K-number	K210925
Device name	Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
Applicant	Boston Scientific
Product code	GEX
Device class	Class II
Decision date	Apr 28, 2021
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber

Everything you need for a 510(k) submission. Nothing you don't.