510(k) DEN190038
- Device
- Surfacer Inside-Out Access Catheter System
- Applicant
- Bluegrass Vascular Technologies, Inc.
- 510(k) number
- DEN190038
- Product code
- QJH
- Decision
- Unknown (DENG)
- Decision date
- 2020-02-10
- Date received
- 2019-08-15
- Regulation
- 870.1342
- Classification name
- Reverse Central Venous Recanalization System
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gabriele G. Niederauer
- Address
- 12500 Network Blvd., Suite 308 San Antonio TX US 78249 78249
FDA Registration Numbers#
- 3015225571
- 3011642792
- 3012536737
- 3015309643
- 3007544634
- 1721504
- 3033589330
- 3006950086
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QJH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | 2025-09-10 |