Name: Predicase
Price: 199 USD

K-number	K172929
Device name	Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Applicant	Boston Scientific Corporation
Product code	LJE
Device class	Class U
Decision date	Jan 10, 2018
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath

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