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510(k) K250529

Device
Globe Introducer (601-01001)
Applicant
Kardium, Inc.
510(k) number
K250529
Product code
DRA
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-03
Date received
2025-02-24
Regulation
870.1280
Classification name
Catheter, Steerable
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ricardo Romero
Address
8518 Glenlyon Pkwy. Unit 155 Burnaby CA V5J 0B6 V5J 0B6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation2023-12-11
K232321FlexCath Contour™ Steerable SheathMedtronic, Inc.2023-10-31
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K211100AcQGuide MAX Steerable SheathAcutus Medical, Inc.2021-05-14
K202620FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP2020-11-13
K192422Steerable Introducer 12FFreudenberg Medical, LLC2019-10-04
K190167MitraClip G4 Steerable Guide CatheterAbbott2019-05-29
K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP2018-11-26
K172394Steerable Guide CatheterAbbott Vascular2017-09-06
K162925AcQGuide Steerable SheathAcutus Medical, Inc.2017-04-06
K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc.2016-09-20
K161985Steerable Guide CatheterAbbott Vascular2016-08-07
K152310HeartLight Deflectable SheathCardiofocus, Inc.2016-02-24