Name: Predicase
Price: 199 USD

K-number	K963187
Device name	MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
Applicant	Boston Scientific Corp
Product code	DSP
Device class	Class II
Decision date	Nov 4, 1996
Decision	Substantially Equivalent
Regulation	870.3535

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MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C

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