← FDA Medical Device Classifications
Accessory Equipment, Cardiopulmonary Bypass
KRI · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.4200
Classification
- FDA Product Code
KRI- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 870.4200
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 42
- Registered establishments
- 46
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown