Pantheris Catheter
510(k) K160827
Pantheris Catheter is a Class II device made by Avinger, Inc., cleared under FDA 510(k) K160827 on 21 Apr 2016, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160827 | Date21 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K160827
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCW
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4875
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MCW (Catheter, Peripheral, Atherectomy).
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- AMPLATZ THROMBECTOMY DEVICE(ATD 603, 602, 801, 802)/FOOT PEDAL ASSEMBLY(AK 200) by Microvena Corp.
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- Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters by Spectranetics Corporation
- HEART TECHNOLOGY ROTABLATOR WIRECLIP by Heart Technology, Inc.
- THROMCAT THROMBECTOMY CATHETER SYSTEM by Kensey Nash Corp.
- FOGARTY 160245F by Edwards Lifesciences LLC
- PHOENIX 5F TRACKING ATHERECTOMY CATHETER, PHOENIX 6F TRACKING ATHERECTOMY CATHETER, PHOENIX 7D DEFLECTING ATHERECTOMY CA by Atheromed, Inc.