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

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit Manifold With Integrated Transducer, Model 203ltchn-r; 503ltchn-r; 203ltphn-r,203ltchwn-r; 503ltchwn-r; 203l.

Pre-market Notification Details

• Device ID: K100319
• 510k Number: K100319
• Device Name: MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L
• Classification: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Contact: Jeff Carlstrom
• Correspondent: Jeff Carlstrom; MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095
• Product Code: DTL
• CFR Regulation Number: 870.4290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-04
• Decision Date: 2010-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884450312244	K100319	000
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