Identity
- Trade Name
- Aspirex® S 6F 135cm FDA UDI
- Generic Name
- Thrombectomy rotational catheter FDA UDI
- Device Name
- The Aspirex® S catheter (gauge 6F; length 135cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in venous vasculature. FDA UDI
- Model / Reference
- 80203 FDA UDI
- Description
- The Aspirex® S catheter (gauge 6F; length 135cm) is over-the-wire, single use, percutaneous device for the treatment of occlusions in venous vasculature. FDA UDI
Identifiers
- Catalog Number
- 80203 FDA UDI
- Primary DI / UDI-DI
- 07640142810438 FDA UDI
- 510(k) Number
- K220270 FDA UDI
- FDA Product Code
- QEW FDA UDI
- GMDN Term
- Thrombectomy rotational catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 6 French FDA UDICatheter Working Length — 135 Centimeter FDA UDI
Aspirex® S 6F 135cm by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Straub Medical AG
Sources (1)
- FDA UDI d33c3ef6-b0ca-4554-83f7-51242d191552 38 fields · synced May 30, 2026