510(k) DEN190038
DEN190038 is an FDA 510(k) premarket notification submitted by Bluegrass Vascular Technologies, Inc. for the device "Surfacer Inside-Out Access Catheter System". The FDA issued a decision of De Novo Granted on February 10, 2020. The device falls under product code QJH (Reverse Central Venous Recanalization System), a Class II device regulated under 21 CFR 870.1342.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 10, 2020
- Date Received
- August 15, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reverse Central Venous Recanalization System
- Device Class
- Class II
- Regulation Number
- 870.1342
- Review Panel
- CV
- Submission Type
A reverse central venous recanalization system is a prescription device intended for obtaining central venous access to facilitate catheter insertion into the central venous system. Reverse recanalization involves the initiation of an access path from within the vein and then progressing to the skin for patients with upper body venous occlusions or other conditions that preclude central venous access by other methods.