# Sizer, Heart-Valve, Prosthesis
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=DTI)
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