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Stellar Guide Catheter

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name
Stellar Guide Catheter FDA UDI
Generic Name
Vascular guide-catheter, single-use FDA UDI
Device Name
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 is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Stellar Guide Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use use only. FDA UDI
Model / Reference
STLR071105 FDA UDI
Description
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 is offered in various sizes to accommodate physician preferences and anatomical variations. A peelable split introducer sheath is provided in the package to provide support and facilitate the introduction of the distal tip of the Stellar Guide Catheter into an appropriate vascular sheath. The catheter and introducer sheath are provided sterile, non-pyrogenic, and are intended for single use use only. FDA UDI

Identifiers

Catalog Number
N/A FDA UDI
Primary DI / UDI-DI
00840303713531 FDA UDI
510(k) Number
K234074 FDA UDI
FDA Product Code
DQY FDA UDI
QJP FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 105 Centimeter FDA UDI

Category: Vascular guide-catheter, single-use

Stellar Guide Catheter by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Cleared under the same submission

K234074 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Balt Usa Llc

Sources (1)

  • FDA UDI 44f4afa1-9021-4295-86e4-792eecdd59bc 38 fields · synced May 30, 2026