Corvocet Biopsy System

Instrument, Biopsy

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Corvocet Biopsy System.

Pre-market Notification Details

• Device ID: K153337
• 510k Number: K153337
• Device Name: Corvocet Biopsy System
• Classification: Instrument, Biopsy
• Applicant: MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY South Jordan, UT 84095
• Contact: Ileana Davis
• Correspondent: Ileana Davis; MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PARKWAY South Jordan, UT 84095
• Product Code: KNW
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-11-19
• Decision Date: 2016-03-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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