FDA.reportPublic FDA data

Carrier XL Delivery Catheter

Primary DI
00840303713470
Brand
Carrier XL Delivery Catheter
Company
BALT USA LLC
Model
CR8088152
Catalog number
N/A
Device description
The Carrier XL Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier XL Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier XL Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier XL Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only.
Published
2025-10-24
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
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840303713470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840303713470008403037134708403037134700840303713470

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to water, sunlight, extreme temperatures, and high humidity during storage. Store the Carrier Delivery Catheter in a cool, dry place under controlled

Contacts#

Phone, Email table
PhoneEmail
1-949-788-1443customerservice@balt-usa.com

Regulatory Flags#

DUNS number
945543689
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
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
00810068568998Next Generation 088 CatheterNG088110N/A2026-10-01
00840303713104Next Generation 088 CatheterNG088115N/A2026-10-01
00840303713128Carrier XL Delivery CatheterCR8088142N/A2025-10-24
00840303713135Carrier XL Delivery CatheterCR8088162N/A2025-10-24
00840303713593Stellar Guide CatheterSTLR071125N/A2025-08-19
00840303713609Stellar Guide CatheterSTLR081105N/A2025-08-19
00840303713616Stellar Guide CatheterSTLR081115N/A2025-08-19
00840303713531Stellar Guide CatheterSTLR071105N/A2025-06-09
00840303713548Stellar Guide CatheterSTLR071110N/A2025-06-09
00840303713555Stellar Guide CatheterSTLR071115N/A2025-06-09
00840303713562Stellar Guide CatheterSTLR074105N/A2025-06-09
00840303713579Stellar Guide CatheterSTLR074110N/A2025-06-09
00840303713586Stellar Guide CatheterSTLR074115N/A2025-06-09
00840303713487Carrier™ Delivery CatheterCR7071162N/A2025-04-02
00840303713494Carrier™ Delivery CatheterCR7074162N/A2025-04-02
00840303713500Carrier™ Delivery CatheterCR8081162N/A2025-04-02
00840303711780MEGA Ballast Distal Access PlatformMEGABT09180N/A2025-02-19
00840303711797MEGA Ballast Distal Access PlatformMEGABT09190N/A2025-02-19
00840303711803MEGA Ballast Distal Access PlatformMEGABT091100N/A2025-02-19
00840303711810MEGA Ballast Distal Access PlatformMEGABT091110N/A2025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
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00850085183033FreeClimb 46 Catheter x143 cm with Tenzing 4ROUTE 92 MEDICALQJP2026-10-12
00850085183040Tenzing 4 Delivery CatheterROUTE 92 MEDICALQJP2026-10-12
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00810068568998Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCQJP2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
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00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00857545008158ZebraQ'APEL MEDICAL LLCDQY2025-01-03
00857545008165ZebraQ'APEL MEDICAL LLCDQY2025-01-03