510(k) K252527
- Device
- Surfacer Inside-Out Access Catheter System
- Applicant
- Merit Medical System, Inc.
- 510(k) number
- K252527
- Product code
- QJH
- Decision
- Unknown (SESU)
- Decision date
- 2025-09-10
- Date received
- 2025-08-11
- Regulation
- 870.1342
- Classification name
- Reverse Central Venous Recanalization System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Desiree Bond
- Address
- 1600 W. Merit Pkwy. South Jordan UT US 84095 84095
FDA Registration Numbers#
- 3006950086
- 3007544634
- 3011642792
- 1721504
- 3012536737
- 3033589330
- 3015309643
- 3015225571
Source Documents#
Other 510(k) Records For Product Code QJH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN190038 | Surfacer Inside-Out Access Catheter System | Bluegrass Vascular Technologies, Inc. | 2020-02-10 |