# Reflow Medical, Inc (manufacturer, San Clemente, CA): 1 new FDA device listing, incl. catheter for crossing total occlusions

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Reflow Medical, Inc |
| Owner / operator | Reflow Medical |
| Role | Manufacturer |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device |
| Location | San Clemente, CA, US |
| New listings | 1 |
| Devices | Catheter For Crossing Total Occlusions |
| Product codes | PDU |
| Device classes | Class II |
| Medical specialties | Cardiovascular |
| Brand names | Kiba CTO Crossing Catheter |
| First new listing | 2026-08-31 |
| Latest new listing | 2026-08-31 |
| FDA registration number | 3008789872 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.