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WiSE CRT System

EBR Systems, Inc. · Model 2000 · UDI-DI 00859244007067

SEG Prescription
0
510(k) clearances
100
Adverse events (7 deaths)
0
Recalls
2
Facilities

Description

Delivery Sheath

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.