FDA.reportPublic FDA data

Globe® Introducer

Primary DI
07540162100185
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
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.

Regulatory Flags#

DUNS number
248480043
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07540162100192Globe® Introducer601-010012025-09-15
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
00810024671991AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024672004AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-29
00810024670314AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670536AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670543AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024670550AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-01-12
00810024671342AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671359AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671366AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671373AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671380AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671397AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671403AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671410AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671427AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671434AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671441AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671571AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671588AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671595AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671601AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671618AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671625AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671632AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671649AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671687AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671694AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671700AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671731AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05
00810024671748AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2025-11-05