Identity
- Trade Name
- Aspire Max 6 Aspiration Catheter 55cm FDA UDI
- Generic Name
- General-purpose syringe, single-use FDA UDI
- Device Name
- ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. FDA UDI
- Model / Reference
- A6-055 FDA UDI
- Description
- ASPIRE MAX 6 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature. FDA UDI
Identifiers
- Catalog Number
- A6-055 FDA UDI
- Primary DI / UDI-DI
- B090A60550 FDA UDI
- FDA Product Code
- DXE FDA UDI
- GMDN Term
- General-purpose syringe, single-use 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
Aspire Max 6 Aspiration Catheter 55cm by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- ZIEN Medical Technologies, LLC
Sources (1)
- FDA UDI 85d1a99e-b3e5-4412-a617-f485bb3acde9 35 fields · synced Jun 8, 2026