← FDA Medical Device Classifications
Sizer, Heart-Valve, Prosthesis
DTI · Class I — Low Risk (general controls) · Cardiovascular · 21 CFR 870.3945
Classification
- FDA Product Code
DTI- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 870.3945
- 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
- 7
- Registered establishments
- 22
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown