# Ventricular Bypass (Assist) Device
> **Product code: OKR** · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.3545
## Classification
- **FDA Product Code:** OKR
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 870.3545
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow  for <6 hours. The device is either totally or partially implanted in the body.

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