# Cardiovascular Delivery Catheter System Positioning And Stabilization Device
> **Product code: QWA** · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.3955
## Classification
- **FDA Product Code:** QWA
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 870.3955
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A cardiovascular delivery catheter system positioning and stabilization device is a platform device or a part of a platform device that aids the positioning and stabilization of delivery catheter systems during cardiovascular interventional procedures (e.g., transcatheter valvular interventions). The device only provides mechanical support and does not include any electrical or robotic components. The device may be for single use or reusable.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 19
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QWA)
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