Identity
- Trade Name
- PRONTO FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- PRONTO V4 5.5F FDA UDI
- Model / Reference
- IPN922584 FDA UDI
- Description
- PRONTO V4 5.5F FDA UDI
Identifiers
- Catalog Number
- 4005 FDA UDI
- Primary DI / UDI-DI
- 10841156108977 FDA UDI
- 510(k) Number
- K103405 FDA UDI
- FDA Product Code
- QEZ FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 5.5 French FDA UDI
Category: Thrombectomy suction catheter
Pronto by Teleflex Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Teleflex Incorporated
Sources (1)
- FDA UDI ff039b24-248d-443b-a1b7-2265949c89ba 37 fields · synced May 31, 2026