Identity
- Trade Name
- Approach® CTO-12 EUDAMEDApproach FDA UDI
- Generic Name
- Peripheral vascular guidewire, manual FDA UDI
- Device Name
- Approach® Micro Wire Guide [CTO-6, CTO-12, CTO-18, CTO-25] EUDAMEDApproach, CTO-12 Micro Wire Guide FDA UDI
- Model / Reference
- CMW-14-300-12G EUDAMEDG50791 FDA UDI
- Description
- Approach, CTO-12 Micro Wire Guide FDA UDI
Identifiers
- Catalog Number
- CMW-14-300-12G FDA UDI
- Primary DI / UDI-DI
- 00827002507913 EUDAMEDFDA UDI
- Basic UDI-DI
- 0827002CINC011-010_AF7 EUDAMED
- FDA Product Code
- PDU FDA UDI
- EMDN Code
- C04020202 PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
- GMDN Term
- Peripheral vascular guidewire, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Peripheral vascular guidewire, manual
Approach by Cook Incorporated — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Peripheral vascular guidewire, manual.
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- Merit Laureate® — Merit Medical Systems, Inc. · Class II
- Nit-Vu — ANGIODYNAMICS, INC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI 110cb887-1f42-40f7-805a-bad93444b610 36 fields · synced Jun 18, 2026
- EUDAMED abe9d952-2493-4646-b534-a5407e3f7e2c 61 fields · synced Jun 18, 2026