Name: Predicase
Price: 199 USD

K-number	K210083
Device name	Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
Applicant	Penumbra, Inc.
Product code	QEW
Device class	Class II
Decision date	Feb 9, 2021
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 7, Indigo Aspiration System Separator 7, Lightning 7

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