Reverse Central Venous Recanalization System
The Reverse Central Venous Recanalization System is a prescription Class 2 cardiovascular device intended for obtaining central venous access to facilitate catheter insertion into the central venous system using a reverse recanalization technique, where the access path is initiated from within the vein and progressed outward to the skin, specifically for patients with upper body venous occlusions or conditions that preclude standard central venous access methods. It requires 510(k) clearance and is regulated under 21 CFR 870.1342 within the Cardiovascular medical specialty. The product code is QJH. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QJH
- Device Class
- FDA class 2
- Regulation Number
- 870.1342
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.