Pantheris A400
Pantheris A400 is a Class II device made by Avinger, Inc., listed in FDA GUDID since 21 Mar 2019 (UDI-DI 00851354004370), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851354004370 | Date21 Mar 2019 | StatusListed |
Official records
- AccessGUDID record 00851354004370
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Pantheris
- Generic name
- Mechanical atherectomy system, coronary/peripheral
- Model / Ref / Catalog
- A400
- Primary DI / UDI-DI
- 00851354004370
- FDA product code
- NQQ, MCW
- GMDN term
- Mechanical atherectomy system, coronary/peripheral
- Device class
- Class II
- Regulation number
- 892.1560, 870.4875
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization
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