Name: Predicase
Price: 199 USD

K-number	K162625
Device name	SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters
Applicant	B. Braun Interventional Systems, Inc.
Product code	LOX
Device class	Class II
Decision date	Jun 12, 2017
Decision	Substantially Equivalent
Regulation	870.5100

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Source

View the full FDA submission: accessdata.fda.gov

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SeQuent Neo Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Catheters

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