Name: Predicase
Price: 199 USD

K-number	K993933
Device name	14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO
Applicant	Arrow Intl., Inc.
Product code	MPB
Device class	Class II
Decision date	Sep 14, 2000
Decision	Substantially Equivalent
Regulation	876.5540

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Source

View the full FDA submission: accessdata.fda.gov

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14 FR TWO-LUMEN HEMODIALYSIS CATHERIZATION KIT WITH BLUE FLEXTIP ARROWG+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS, PRO

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