Name: Predicase
Price: 199 USD

K-number	K192981
Device name	Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12
Applicant	Penumbra, Inc.
Product code	QEW
Device class	Class II
Decision date	May 28, 2020
Decision	Substantially Equivalent
Regulation	870.5150

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Source

View the full FDA submission: accessdata.fda.gov

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Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12

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