# Temporary Non-Roller Type Right Heart Support Blood Pump
> **Product code: PYX** · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.4360
## Classification
- **FDA Product Code:** PYX
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 870.4360
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** Y
- **Implant:** N
- **Third-party review:** N
## Definition

Providing temporary partial or full right heart circulatory support.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PYX)
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