K-number	K993966
Device name	8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
Applicant	Arrow Intl., Inc.
Product code	DSP
Device class	Class II
Decision date	Feb 18, 2000
Decision	Substantially Equivalent
Regulation	870.3535

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View the full FDA submission: accessdata.fda.gov

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8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER

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