Cleared Special

Intra-Operative Positioning System (IOPS?) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS?) (Guidewire Handle)

K242133 · Centerline Biomedical, Inc. · Cardiovascular
Oct 2024
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K242133 is an FDA 510(k) clearance for the Intra-Operative Positioning System (IOPS?) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS?) (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 October 11, 2024, 81 days after receiving the submission on July 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K242133 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2024
Decision Date October 11, 2024
Days to Decision 81 days
Submission Type Special
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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