FDA.reportPublic FDA data

Stellar Guide Catheter

Primary DI
00840303709619
Brand
Stellar Guide Catheter
Company
BALT USA LLC
Model
STLR071128
Catalog number
N/A
Device description
The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter dimensions are included on the individual device label. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations.
Published
2024-07-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234074000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234074000Next Generation Access CatheterBalt USA, LLC2024-07-02QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840303709619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840303709619008403037096198403037096190840303709619

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Inner Diameter0.071Inch
Length128Centimeter
Outer Diameter0.083Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store the Stellar Guide Catheter in a cool, dry, place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
945543689
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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00840303714323Optima Coil System (OptiOne Coil System)OPTIONE4MN/A2026-01-28
00840303714330Optima Coil System (OptiOne Coil System)OPTIONE4LN/A2026-01-28
00840303714347Optima Coil System (OptiOne Coil System)OPTIONE45SN/A2026-01-28
00840303714354Optima Coil System (OptiOne Coil System)OPTIONE45MN/A2026-01-28
00840303714361Optima Coil System (OptiOne Coil System)OPTIONE45LN/A2026-01-28
00840303714378Optima Coil System (OptiOne Coil System)OPTIONE5SN/A2026-01-28
00840303714385Optima Coil System (OptiOne Coil System)OPTIONE5MN/A2026-01-28
00840303714392Optima Coil System (OptiOne Coil System)OPTIONE5LN/A2026-01-28
00840303714408Optima Coil System (OptiOne Coil System)OPTIONE5XLN/A2026-01-28
00840303714415Optima Coil System (OptiOne Coil System)OPTIONE55SN/A2026-01-28
00840303714422Optima Coil System (OptiOne Coil System)OPTIONE55MN/A2026-01-28
00840303714439Optima Coil System (OptiOne Coil System)OPTIONE55LN/A2026-01-28
00840303714446Optima Coil System (OptiOne Coil System)OPTIONE55XLN/A2026-01-28

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