Name: Predicase
Price: 199 USD

K-number	K070197
Device name	ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
Applicant	Acumen Medical, Inc.
Product code	DYB
Device class	Class II
Decision date	Feb 23, 2007
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY

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