Surfacer Inside-Out Access Catheter System— 510(k) DEN190038

Name: FDA 510(k) clearance DEN190038
Creator: U.S. Food and Drug Administration
Published: 2020-02-10

Unknown

Bluegrass Vascular Technologies, Inc.

FDA 510(k) clearance DEN190038 for Surfacer Inside-Out Access Catheter System, Unknown on 2020-02-10. Applicant: Bluegrass Vascular Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Bluegrass Vascular Technologies, Inc.
Product code: Code QJH
Device class: Class 2
Regulation: 21 CFR 870.1342
Advisory panel: Cardiovascular
Date received: 2019-08-15
Decision date: 2020-02-10
Decision: Unknown
Clearance type: Direct
Location: San Antonio, TX, US

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