# Catheter For Crossing Total Occlusions
> **Product code: PDU** · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250
## Classification
- **FDA Product Code:** PDU
- **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

To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.

## Market data
- **Cleared 510(k) submissions:** 57
- **Registered establishments:** 42
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PDU)
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