Chrysalis Intelligence · Sponsors · Kardium, Inc.

Kardium, Inc.

Burnaby, CA · 2 510(k) clearances · 6 PMAs

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Total clearances
2
2025-06-03 → 2025-06-25
Last 12 months
0
Product codes
2
Most recent
2025-06-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DQK Computer, Diagnostic, Programmable Class II Cardiovascular 1 2025-06-25
DRA Catheter, Steerable Class II Cardiovascular 1 2025-06-03
Class III

PMA approvals (6)

Total PMA records
6
Originals + supplements
Distinct product codes
1
First decision
2025-08-27
Most recent
2026-06-23
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-06-23 P240044-S001 Globe® Catheter and Globe® Pulsed Field System Normal 180 Day Track No User Fee QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2026-06-12 P240044-S005 Globe® Catheter; Globe® Pulsed Field System 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2026-02-18 P240044-S002 Globe Catheter (601-01000) Real-Time Process QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2026-01-09 P240044-S004 Globe® Catheter; Globe® Pulsed Field System 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2026-01-06 P240044-S003 Globe® Pulsed Field System 30-Day Notice QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
2025-08-27 P240044 Globe® Pulsed Field System Original QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation Unknown
Filings

All 510(k) clearances (2)

Date K-number Device Code Class Specialty
2025-06-25 K250747 Globe® Pulsed Field System DQK Class II Cardiovascular
2025-06-03 K250529 Globe Introducer (601-01001) DRA Class II Cardiovascular
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence