← FDA Medical Device Classifications
Right Ventricular Bypass (Assist) Device
OJE · f · Unknown
Classification
- FDA Product Code
OJE- Device class
- f
- Regulation
- —
- Review panel
- CV
- Medical specialty
- Unknown
- Submission type
- 6
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 5
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown