Bashir S-B Endovascular Catheter, Ref. No. 7101— 510(k) K192598

Name: FDA 510(k) clearance K192598
Creator: U.S. Food and Drug Administration
Published: 2019-10-18

Substantially Equivalent

Thrombolex, Inc.

FDA 510(k) clearance K192598 for Bashir S-B Endovascular Catheter, Ref. No. 7101, Substantially Equivalent on 2019-10-18. Applicant: Thrombolex, Inc.. Device class: 2.

Clearance details

Applicant: Thrombolex, Inc.
Product code: Code QEY
Device class: Class 2
Regulation: 21 CFR 870.5150
Advisory panel: Cardiovascular
Date received: 2019-09-20
Decision date: 2019-10-18
Decision: Substantially Equivalent
Clearance type: Special
Location: New Britain, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.