510(k) K153337

Device
Corvocet Biopsy System
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K153337
Product code
KNW  
Decision
Substantially Equivalent (SESE)
Decision date
2016-03-25
Date received
2015-11-19
Regulation
876.1075
Classification name
Instrument, Biopsy
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Ileana Davis
Address
1600 W. Merit Pkwy. South Jordan UT US 84095 84095

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

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10884450373825CorVocet™Merit Medical Systems, Inc.2018-01-22
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10884450373931CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373948CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373955CorVocet™Merit Medical Systems, Inc.2018-01-22
20884450373976CorVocet™Merit Medical Systems, Inc.2018-01-22
20884450373761CorVocet™Merit Medical Systems, Inc.2018-01-22
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10884450373962CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373580CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373573CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373566CorVocet™Merit Medical Systems, Inc.2018-01-22
20884450373556CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373542CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373535CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373528CorVocet™Merit Medical Systems, Inc.2018-01-22
20884450373518CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373498CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373474CorVocet™Merit Medical Systems, Inc.2018-01-22
20884450373457CorVocet™Merit Medical Systems, Inc.2018-01-22
10884450373443CorVocet™Merit Medical Systems, Inc.2018-01-22
20884450373433CorVocet™Merit Medical Systems, Inc.2018-01-22

Legacy Summary

summary

FDA Review

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