Name: Predicase
Price: 199 USD

K-number	K142301
Device name	Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath
Applicant	Cook Vascular, Inc.
Product code	DRE
Device class	Class II
Decision date	Nov 12, 2014
Decision	Substantially Equivalent
Regulation	870.1310

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Source

View the full FDA submission: accessdata.fda.gov

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Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath

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