Pantheris SV
510(k) K182341
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK182341 | Date9 Apr 2019 | StatusActive |
Official records
- FDA 510(k) database K182341
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- Withdrawn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
Overview
AI-generated summary, 25 Sep 2026
Pantheris SV is a catheter-based atherectomy device designed for the diagnosis and treatment of Peripheral Artery Disease (PAD). It is an image-guided system intended for use in vascular procedures.
The device is supplied sterile and is intended for single use. It is a Class II medical device regulated under 870.4875 and has received FDA 510(k) clearance (K182341).
Devices cleared under K182341
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Pantheris SV A140-SV | A140-SV / A140-SV | 00851354004417 | — | On the market |
Similar devices
Other devices filed under FDA product code MCW (Catheter, Peripheral, Atherectomy).
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- DIAMONDBACK 360* ORBITAL ATHERECTOMY SYSTEM, STEALTH 360* ORBITAL PAD SYSTEM by Cardiovascular Systems, Inc.
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