Name: Predicase
Price: 199 USD

K-number	K190106
Device name	Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle
Applicant	Centerline Biomedical, Inc.
Product code	DQK
Device class	Class II
Decision date	Jun 24, 2019
Decision	Substantially Equivalent
Regulation	870.1425

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Source

View the full FDA submission: accessdata.fda.gov

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Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle

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