Name: Predicase
Price: 199 USD

K-number	K981782
Device name	LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM
Applicant	Arrow Intl., Inc.
Product code	DYB
Device class	Class II
Decision date	Aug 12, 1998
Decision	Substantially Equivalent
Regulation	870.1340

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Source

View the full FDA submission: accessdata.fda.gov

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LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM

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