TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE)— 510(k) K891588

Name: FDA 510(k) clearance K891588
Creator: U.S. Food and Drug Administration
Published: 1989-09-28

Substantially Equivalent

Ideal Medical, Inc.

FDA 510(k) clearance K891588 for TRI-LUMEN INTRA VASCULAR BALLOON CATHETER (GU USE), Substantially Equivalent on 1989-09-28. Applicant: Ideal Medical, Inc.. Device class: 2.

Clearance details

Applicant: Ideal Medical, Inc.
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 1989-03-17
Decision date: 1989-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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