← FDA Medical Device Classifications
Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
QJZ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4100
Classification
- FDA Product Code
QJZ- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 870.4100
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- Y
- Implant
- N
- Third-party review
- N
Definition
Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure.
Market data
- Cleared 510(k) submissions
- 3
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown