Data / Medical devices / United States / AtriCure, Inc.
AtriCure, Inc.: FDA-registered device maker in Pleasanton, CA, United States, 6 510(k) clearances
AtriCure, Inc. is registered with the FDA (registration 3020954746) in Pleasanton, CA, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020954746
- Address
- 3875 Hopyard Rd. Suite 160, Pleasanton, CA, United States, 94588
- Owner or operator
- ATRICURE, INC. (9045049)
- Roles
- Specification developer
- First device listed
- November 7, 2019
- Registered through
- 2026
- Brand names listed
- EPi-Ease, EndoCATH Occlusion Balloon, FindrWirz Guide Wire System, LARIAT RS Suture Delivery Device, LARIAT Suture Delivery Device; SofTIP Guide Cannula, LARIAT+ Suture Delivery Device, SureCUT Suture Cutter, TenSURE Suture Tightener
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Percutaneous | DQY | 2 | Specification developer | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Ligature Passing And Knot Tying | HCF | 1 | Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Specification developer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Specification developer | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 2 | Specification developer | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2024 | K233959 | EPi-Ease Epicardial Access Device (EAS) | DYB | Substantially Equivalent | AtriCure, Inc. | accessdata.fda.gov |
| November 25, 2015 | K153096 | LARIAT RS Suture Delivery Device | GAT | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| September 12, 2014 | K142241 | LARIAT sulture Delivery Device | GAT | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| May 6, 2009 | K090385 | LARIAT II SUTURE DELIVERY DEVICE | GAT | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| August 11, 2008 | K080364 | FINDRWIRZ GUIDE WIRE SYSTEM | DQX | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
| February 8, 2008 | K070126 | OCCLUSION BALLOON CATHETER | DQY | Substantially Equivalent | Sentreheart, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Nonabsorbable, Synthetic, Polyethylene
- All makers of Instrument, Ligature Passing And Knot Tying
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Cutter, Surgical
- All makers of Introducer, Catheter
- All makers of Catheter, Percutaneous
Updated February 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.