# Percutaneous Catheter, Ultrasound
> **Product code: PPN** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250
## Classification
- **FDA Product Code:** PPN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 870.1250
- **Review panel:** CV
- **Medical specialty:** Cardiovascular
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Intended for ultrasound wave enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature.

## Market data
- **Cleared 510(k) submissions:** 12
- **Registered establishments:** 12
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PPN)
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