FDA Registration
Active
🇺🇸 United States
AtriCure, Inc.
Reg #: 3020954746
·
FEI: 3020954746
·
Expires 2026
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- AtriCure, Inc.
- Registration Number
- 3020954746
- FEI Number
- 3020954746
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3875 Hopyard Rd., Suite 160
- City
- Pleasanton
- State
- CA
- ZIP
- 94588
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090385
Owner / Operator
- Firm Name
- ATRICURE, INC.
- Operator Number
- 9045049
- Address
- 7555 Innovation Way, --
- City
- Mason
- State
- OH
- Postal Code
- 45040
- Country
- US
- Correspondent
- Janet Hillard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2019-11-07 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2019-11-07 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-11-07 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2024-07-10 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2019-11-07 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2019-11-07 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2019-11-07 |
Proprietary Names
LARIAT Suture Delivery Device; SofTIP Guide Cannula
TenSURE Suture Tightener
EPi-Ease
LARIAT RS Suture Delivery Device
SureCUT Suture Cutter
EndoCATH Occlusion Balloon
LARIAT+ Suture Delivery Device
FindrWirz Guide Wire System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility