510(k) K190106

Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle by Centerline Biomedical, Inc. — Product Code DQK

K190106 is an FDA 510(k) premarket notification submitted by Centerline Biomedical, Inc. for the device "Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle". The FDA issued a decision of Substantially Equivalent on June 24, 2019. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Centerline Biomedical, Inc. has at least 6 other 510(k) clearances on record.