Name: Predicase
Price: 199 USD

K-number	K980780
Device name	DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
Applicant	Datascope Corp.
Product code	DSP
Device class	Class II
Decision date	May 29, 1998
Decision	Substantially Equivalent
Regulation	870.3535

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View the full FDA submission: accessdata.fda.gov

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DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES

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