ULTRAGUIDE CTG 2000SA— 510(k) K022354

Substantially Equivalent

Ultraguide , Ltd.

FDA 510(k) clearance K022354 for ULTRAGUIDE CTG 2000SA, Substantially Equivalent on 2002-08-13. Applicant: Ultraguide , Ltd..

Clearance details

Applicant: Ultraguide , Ltd.
Product code: Code JAK
Advisory panel: Radiology
Date received: 2002-07-19
Decision date: 2002-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Hasbrouck Heights, NJ, US

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Adverse events under product code JAK

product code JAK

Death: 27
Injury: 571
Malfunction: 779
Total: 1,377

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.