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MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L

K100319 Class II Traditional
Decision Date
2010-04-28
Sponsor / Applicant
Merit Medical Systems, Inc.

Technical Specification

510(k) Submission ID K100319
Product Code DTL
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4290
Decision Date 2010-04-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L received FDA 510(k) clearance under submission number K100319, sponsored by Merit Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-04-28.

Classification & Regulation

This clearance is catalogued under FDA product code DTL and 21 CFR 870.4290, within the Cardiovascular review panel as a Class II device.