Identity
- Trade Name
- Tigereye FDA UDI
- Generic Name
- Atheroma crossing microdissection catheter, coronary FDA UDI
- Device Name
- The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. FDA UDI
- Model / Reference
- O300 FDA UDI
- Description
- The Tigereye System is intended to facilitate the intraluminal placement conventional guide wires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. FDA UDI
Identifiers
- Catalog Number
- O300 FDA UDI
- Primary DI / UDI-DI
- 00851354004493 FDA UDI
- 510(k) Number
- K201330 FDA UDI
- FDA Product Code
- PDU FDA UDINQQ FDA UDI
- GMDN Term
- Atheroma crossing microdissection catheter, coronary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI892.1560 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Atheroma crossing microdissection catheter, coronary
Tigereye by Avinger, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Avinger, Inc.
Sources (1)
- FDA UDI 1c0d4ea4-7b4c-4a0b-b6c0-5686c0edf6a7 36 fields · synced Jun 8, 2026