FDA.report

510(k) K153502

Device
ClariVein IC
Applicant
VASCULAR INSIGHTS, LLC
510(k) number
K153502
Product code
KRA  
Decision
Substantially Equivalent (SESE)
Decision date
2016-01-06
Date received
2015-12-07
Regulation
870.1210
Classification name
Catheter, Continuous Flush
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LORRAINE M. HANLEY
Address
1 Pine Hill Dr., Two Batterymarch Park, Suite 100 Quincy MA US 02169 02169

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00884450429242ClariVein® ICMerit Medical Systems, Inc.2020-08-25
00884450429280ClariVein® ICMerit Medical Systems, Inc.2020-06-30
10884450429263ClariVein® ICMerit Medical Systems, Inc.2019-11-27
10884450412838ClariVein® ICMerit Medical Systems, Inc.2019-10-02
10884450412821ClariVein® ICMerit Medical Systems, Inc.2019-09-13
10884450412814ClariVein® ICMerit Medical Systems, Inc.2019-09-13

Legacy Summary

summary

FDA Review

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