Cleared Special

Intra-Operative Positioning System (IOPS?) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)

K230309 · Centerline Biomedical, Inc. · Cardiovascular
Jun 2023
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K230309 is an FDA 510(k) clearance for the Intra-Operative Positioning System (IOPS?) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1), 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 21, 2023, 138 days after receiving the submission on February 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K230309 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2023
Decision Date June 21, 2023
Days to Decision 138 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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