Merge Hemo, Model RCSV2— 510(k) K233326

Clearance details

Applicant

Merge Healthcare Incorporated

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2023-09-29

Decision date

2024-06-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hartland, WI, US

• K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
• K262005 — Affera Integrated Mapping System2026-08-21
• K253576 — CorVista System® with PCWP Add-On2026-07-26
• K262006 — EnSite X EP System2026-07-15
• K252978 — ScioCardio ECG Analysis Platform2026-07-09

• K250301 — Merge Universal Viewer (MUV)2025-04-14
• K203104 — IBM iConnect Access2021-01-26
• K192455 — Merge PACS2019-10-17
• K192276 — Merge Cardio2019-09-20
• K182290 — IBM iConnect Access2018-09-25

Death

10

Injury

225

Malfunction

2,123

Other

2

Total

2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2518-2025 — Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices. The system is used for documenting and monitoring patients undergoing diagnostic and interventional catheter-based procedures. The procedures can be performed in the clinical areas of invasive cardiology, interventional radiology, and cardiac electrophysiology.Class II·Ongoing·Merge Healthcare, Inc.·20250811

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233326.