FDA.report

510(k) K211741

Device
Pre-Formed Extra Support Guidewire
Applicant
Lake Region Medical
510(k) number
K211741
Product code
DQX
Decision
Substantially Equivalent (SESE)
Decision date
2021-11-22
Date received
2021-06-07
Regulation
870.1330
Classification name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Deko Hussein
Address
340 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers

Source Documents

510(k) summary PDF

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