Identity
- Trade Name
- Stellar Guide Catheter FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- STLR071132 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00840303709626 FDA UDI
- 510(k) Number
- K234074 FDA UDI
- FDA Product Code
- QJP FDA UDIDQY 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 — 132 Centimeter FDA UDICatheter Inner Diameter — 0.071 Inch FDA UDIOuter Diameter — 0.083 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
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Cleared under the same submission
K234074 also covers:
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
- Stellar Guide Catheter — BALT USA LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Balt Usa Llc
Sources (1)
- FDA UDI 722dbce6-9512-4f44-bcf5-884aa967a5b0 38 fields · synced Jun 8, 2026