FDA.reportPublic FDA data

Globe® Introducer

Primary DI
07540162100192
Brand
Globe® Introducer
Company
Kardium Inc
Model
601-01001
Published
2025-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DRACatheter, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250529000Globe Introducer (601-01001)Kardium, Inc.2025-06-03DRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540162100192PackageGS11In Commercial Distribution
07540162100208PackageGS12In Commercial Distribution
07540162100185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540162100192075401621001927540162100192
07540162100208075401621002087540162100208
07540162100185075401621001857540162100185

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
248480043
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540162100185Globe® Introducer601-010012025-09-15
07540162100239Globe Positioning System (GPS™) Cable601-000362025-09-15
07540162100253Globe Positioning System (GPS™) Electrodes601-000372025-09-15
07540162100277Globe® Catheter Cable601-000462025-09-15
07540162100291Globe® Controller601-000482025-09-15
07540162100307Globe® Workstation601-000642025-09-15
07540162100321Globe® PF Generator601-000602025-09-15
07540162100338Globe® Platform601-000662025-09-15
07540162100352Globe® Catheter Cable Support601-000672025-09-15
07540162100154Globe® Catheter601-010002025-09-15
07540162100246Globe Positioning System (GPS™) Cable601-000362025-09-15
07540162100260Globe Positioning System (GPS™) Electrodes601-000372025-09-15
07540162100284Globe® Catheter Cable601-000462025-09-15
07540162100215Globe® Controller601-000482025-09-15
07540162100314Globe® Workstation601-000642025-09-15
07540162100222Globe® PF Generator601-000602025-09-15
07540162100345Globe® Platform601-000662025-09-15
07540162100369Globe® Catheter Cable Support601-000672025-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024672554AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672561AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672578AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672585AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672592AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672608AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672615AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672622AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672639AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672646AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672653AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672660AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672677AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672684AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672691AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672707AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672714AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672721AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672738AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672745AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672752AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672769AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672776AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672783AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672790AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672806AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672813AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672820AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672837AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
00810024672844AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06