Cleared Traditional

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

K190106 · Centerline Biomedical, Inc. · Cardiovascular
Jun 2019
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K190106 is an FDA 510(k) clearance for the Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Centerline Biomedical, Inc. (Cleveland, US). The FDA issued a Cleared decision on June 24, 2019, 153 days after receiving the submission on January 22, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K190106 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2019
Decision Date June 24, 2019
Days to Decision 153 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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