Cleared Special

Intra-Operative Positioning System (IOPS?) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS?) Viewpoint (Double Curve Catheters)

K241243 · Centerline Biomedical, Inc. · Cardiovascular
Jul 2024
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K241243 is an FDA 510(k) clearance for the Intra-Operative Positioning System (IOPS?) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS?) Viewpoint (Double Curve Catheters), 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 July 24, 2024, 82 days after receiving the submission on May 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K241243 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2024
Decision Date July 24, 2024
Days to Decision 82 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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