FDA.report

510(k) K182167

Device
The ICHOR Panacea Vascular Embolectomy Catheter System
Applicant
ICHOR Vascular, Inc.
510(k) number
K182167
Product code
DXE  
Decision
Substantially Equivalent (SESE)
Decision date
2018-12-21
Date received
2018-08-10
Regulation
870.5150
Classification name
Catheter, Embolectomy
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
Jeff Blair
Address
2865 N Reynolds Rd. Suite 220a Toledo OH US 43615 43615

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
B729ICH7FR0ICHORICHOR VASCULAR, INC.2019-07-31

Legacy Summary

summary

FDA Review

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