510(k) DEN230006
- Device
- esolution
- Applicant
- S4 Medical Corp.
- 510(k) number
- DEN230006
- Product code
- QXU
- Decision
- Unknown (DENG)
- Decision date
- 2023-09-06
- Date received
- 2023-01-24
- Regulation
- 870.5710
- Classification name
- Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- William Fuller
- Address
- 34 S. Main St., Suite 200 Chagrin Falls OH US 44022 44022
FDA Registration Numbers#
- 9613662
- 3019622578
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QXU#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243233 | esolution® Esophageal Retractor | S4 Medical Corp. | 2024-11-09 |