Cleared Traditional

Globe Introducer (601-01001)

K250529 · Kardium, Inc. · Cardiovascular
Jun 2025
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K250529 is an FDA 510(k) clearance for the Globe Introducer (601-01001), a Catheter, Steerable (Class II — Special Controls, product code DRA), submitted by Kardium, Inc. (Burnaby, CA). The FDA issued a Cleared decision on June 3, 2025, 99 days after receiving the submission on February 24, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1280.

Submission Details

510(k) Number K250529 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2025
Decision Date June 03, 2025
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DRA — Catheter, Steerable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1280

Similar Devices — DRA Catheter, Steerable

All 40
FARADRIVE? Steerable Sheath
K233248 · Boston Scientific Corporation · Dec 2023
FlexCath Contour? Steerable Sheath
K232321 · Medtronic, Inc. · Oct 2023
POLARSHEATH? Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP? Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP? EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE? Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE? 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE? CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE? Pressure Sensor
K223824 · Boston Scientific Corporation · Mar 2023
MitraClip G4 Steerable Guide Catheter
K221397 · Abbott Medical · Sep 2022
AcQGuide? VUE Steerable Sheath
K221044 · Acutus Medical, Inc. · May 2022
AcQGuide MAX Steerable Sheath
K211100 · Acutus Medical, Inc. · May 2021