Sentry WEB SmartInterp— 510(k) K153654

Clearance details

Applicant

Carefusion Germany 234 GmbH

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2015-12-21

Decision date

2016-09-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hoechber, DE

• 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

• K150810 — Vyntus / SentrySuite Product Line2015-08-14
• K142959 — Vyntus Walk2015-03-20
• K141936 — MICROBLAB, MICROLOOP2014-12-29
• K133925 — VYNTUS/ SENTRYSUITE PRODUCT LINE2014-08-22
• K122699 — SENTRYSUITE PRODUCT LINE2012-11-19

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 →