FDA.reportPublic FDA data

Magellan™

Primary DI
00815671020161
Brand
Magellan™
Company
HANSEN MEDICAL, INC.
Model
MC10F65
Catalog number
MC10F65
Device description
Magellan Robotic Catheter 10Fr 65cm
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRACatheter, Steerable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRACatheter, SteerableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815671020161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815671020161008156710201618156710201610815671020161

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-650-404-5844xx@xx.xx
1-866-426-0804xx@xx.xx

Regulatory Flags#

DUNS number
128941304
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00815671020017Magellan™MC9F50MC9F502016-09-23
00815671020024Magellan™MC9F65MC9F652016-09-23
00815671020031Magellan™MC9F80MC9F802016-09-23
00815671020116Magellan™MC6F60MC6F602016-09-23
00815671020123Magellan™MC6F95MC6F952016-09-23
00815671020154Magellan™MC10F50MC10F502016-09-23
00815671020178Magellan™MC10F80MC10F802016-09-23
00815671020185Magellan™MCE60MCE602016-09-23
00815671020192Magellan™MCE95MCE952016-09-23
00815671020222Magellan™ML60ML602016-09-23
00815671020239Magellan™ML95ML952016-09-23
00815671020079Magellan™MRCCADMRCCAD2016-09-23
00815671020048Magellan™MACC50MACC502016-09-23
00815671020055Magellan™MACC65MACC652016-09-23
00815671020062Magellan™MACC80MACC802016-09-23
00815671020130Magellan™MA6F60MA6F602016-09-23
00815671020147Magellan™MA6F95MA6F952016-09-23
00815671020208Magellan™MAE60MAE602016-09-23
00815671020215Magellan™MAE95MAE952016-09-23
10815671020007Artisan®06196061962016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810024672554AuST Steerable SheathCENTERPOINT SYSTEMS LLCDRA2026-08-06
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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