meddevicedb.com FDA Device Reference

All’InCath 035M PTA Balloon Dilatation Catheter

K191275 Class II Traditional
Decision Date
2020-01-15
Sponsor / Applicant
Nexstep Medical

Technical Specification

510(k) Submission ID K191275
Product Code LIT
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1250
Decision Date 2020-01-15
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

All’InCath 035M PTA Balloon Dilatation Catheter received FDA 510(k) clearance under submission number K191275, sponsored by Nexstep Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-01-15.

Classification & Regulation

This clearance is catalogued under FDA product code LIT and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.