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BANTAM CATHETER (280MM BALLOON LENGTHS)

K112335 Class II Traditional
Decision Date
2011-10-12
Sponsor / Applicant
ClearStream Technologies , Ltd.

Technical Specification

510(k) Submission ID K112335
Product Code DQY
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.1250
Decision Date 2011-10-12
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

BANTAM CATHETER (280MM BALLOON LENGTHS) received FDA 510(k) clearance under submission number K112335, sponsored by ClearStream Technologies , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-10-12.

Classification & Regulation

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