Chrysalis Intelligence · Sponsors · Centerline Biomedical, Inc.

Centerline Biomedical, Inc.

Cleveland, OH, US · 6 510(k) clearances · 1 recalls (1 Class I)

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Total clearances

6

2023-06-21 → 2026-06-10

Last 12 months

2

Product codes

1

Most recent

2026-06-10

Name variants in FDA filings: Centerline Biomedical / Centerline Biomedical, Inc.

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
DQK	Computer, Diagnostic, Programmable	Class II	Cardiovascular	6	2026-06-10

Safety

Recalls (1)

Class I (serious)

1

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2025-04-11

Date	Severity	Status	Recall #	Product	Code	Reason
2025-04-11	Class I	Ongoing	Z-1760-2025	Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate pl…	—	Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate during use of the guidewire.

Filings

All 510(k) clearances (6)

Date	K-number	Device	Code	Class	Specialty
2026-06-10	K261329	Intra-Operative Positioning System (IOPS) (MC-1);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)	DQK	Class II	Cardiovascular
2026-02-17	K254089	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)	DQK	Class II	Cardiovascular
2025-03-06	K243842	Intra-Operative Positioning System (IOPS®)	DQK	Class II	Cardiovascular
2024-10-11	K242133	Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)	DQK	Class II	Cardiovascular
2024-07-24	K241243	Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)	DQK	Class II	Cardiovascular
2023-06-21	K230309	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)	DQK	Class II	Cardiovascular