FDA.report

510(k) K022117

Device
MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5
Applicant
MERIT MEDICAL SYSTEMS, INC.
510(k) number
K022117
Product code
DRC  
Decision
Substantially Equivalent (SESE)
Decision date
2002-10-11
Date received
2002-07-01
Regulation
870.1390
Classification name
Trocar
Medical specialty
Cardiovascular
Review panel
Cardiovascular
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
STEPHANIE A ERSKINE
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

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K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLESynaptic Medical Limited2014-08-29
K130843SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2014-01-08
K122587BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical2013-02-07
K122832MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2012-12-19
K111644MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2011-10-03
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Legacy Summary

summary

FDA Review

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