Identity
- Trade Name
- Motor (with cord) (Straub Medical®) FDA UDI
- Generic Name
- Mechanical atherectomy/thrombectomy drive system FDA UDI
- Device Name
- The Handle / Motor transmits the power between the Control Unit and the catheter. The Handle contains an electric Motor and a magnetic clutch through which the power is transmitted to the catheter. This is part of the Straub Medical Drive System. FDA UDI
- Model / Reference
- Version 1.0 FDA UDI
- Description
- The Handle / Motor transmits the power between the Control Unit and the catheter. The Handle contains an electric Motor and a magnetic clutch through which the power is transmitted to the catheter. This is part of the Straub Medical Drive System. FDA UDI
Identifiers
- Catalog Number
- 80302 FDA UDI
- Primary DI / UDI-DI
- 07640142810902 FDA UDI
- 510(k) Number
- K172315 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Mechanical atherectomy/thrombectomy drive system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Motor (with cord) (Straub Medical®) by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172315 also covers:
- Drive System (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/220cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/270cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/320cm angled (Straub Medical®) — Straub Medical AG
- SET Rotarex™S 6 F x 110 cm — Straub Medical AG
- SET Rotarex™S 6 F x 135 cm — Straub Medical AG
- SET Rotarex™S 8 F x 110 cm — Straub Medical AG
- SET Rotarex™S 8 F x 85 cm — Straub Medical AG
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 afba06aa-c38c-4a07-ae83-4d1900558aec 37 fields · synced Jun 8, 2026