CVIS ULTRA-SCAN ONE IMAGING CATHETER— 510(k) K893837

Name: FDA 510(k) clearance K893837
Creator: U.S. Food and Drug Administration
Published: 1989-08-22

Substantially Equivalent

Cardiovascular Imaging Systems, Inc.

FDA 510(k) clearance K893837 for CVIS ULTRA-SCAN ONE IMAGING CATHETER, Substantially Equivalent on 1989-08-22. Applicant: Cardiovascular Imaging Systems, Inc.. Device class: 2.

Clearance details

Applicant: Cardiovascular Imaging Systems, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 1989-05-24
Decision date: 1989-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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K942231 — MICROVIEW II/MICRORAIL II CATHETERS1994-08-01
K933517 — AUTOMATIC PULL BACK DEVICE1993-10-15
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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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