Identity
- Trade Name
- CELLO™, Balloon Guide Catheter FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. FDA UDI
- Model / Reference
- 7F FDA UDI
- Description
- The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. FDA UDI
Identifiers
- Catalog Number
- 1610570 FDA UDI
- Primary DI / UDI-DI
- 04544050093460 FDA UDI
- 510(k) Number
- K120781 FDA UDI
- FDA Product Code
- DQY 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Vascular guide-catheter, single-use
CELLO™, Balloon Guide Catheter by Fuji Systems Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vascular guide-catheter, single-use.
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Cleared under the same submission
K120781 also covers:
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp.
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
- Fuji Systems Corp.
Sources (1)
- FDA UDI 90ea7ea8-c45f-465b-92af-8f7c7a2d0fb5 36 fields · synced May 29, 2026