Centerline Biomedical, Inc.

Centerline Biomedical, Inc. has submitted 6 FDA 510(k) premarket notifications since 2019, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Computer, Diagnostic, Programmable . Use the specialty filter in the sidebar to narrow results.

IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)

K254089 · DQK Computer, Diagnostic,... · Cardiovascular

Feb 2026 60d

Intra-Operative Positioning System (IOPS?)

K243842 · DQK Computer, Diagnostic,... · Cardiovascular

Mar 2025 83d

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

K242133 · DQK Computer, Diagnostic,... · Cardiovascular

Oct 2024 81d

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

K241243 · DQK Computer, Diagnostic,... · Cardiovascular

Jul 2024 82d

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 · DQK Computer, Diagnostic,... · Cardiovascular

Jun 2023 138d

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

K190106 · DQK Computer, Diagnostic,... · Cardiovascular

Jun 2019 153d

Centerline Biomedical, Inc. — FDA 510(k) Submissions

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