FDA.report

510(k) K951802

Device
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
Applicant
SCIMED LIFE SYSTEMS, INC.
510(k) number
K951802
Product code
DXT  
Decision
Substantially Equivalent (SESE)
Decision date
1995-07-21
Date received
1995-04-19
Regulation
870.1650
Classification name
Injector And Syringe, Angiographic
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
DIANE M LOWE
Address
One Scimed Pl. Maple Grove MN US 55311 55311

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
20193489078043NAMICMEDLINE INDUSTRIES, INC.2021-07-26
H74904494102NAMICNAVILYST MEDICAL, INC.2016-09-20

Legacy Summary

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FDA Review

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