TEMPORARY OCCLUSION BALLOON SYSTEM— 510(k) K972777

Name: FDA 510(k) clearance K972777
Creator: U.S. Food and Drug Administration
Published: 1998-03-11

Unknown

Percu Surge, Inc.

FDA 510(k) clearance K972777 for TEMPORARY OCCLUSION BALLOON SYSTEM, Unknown on 1998-03-11. Applicant: Percu Surge, Inc.. Device class: 2.

Clearance details

Applicant: Percu Surge, Inc.
Product code: Code MJN
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 1997-07-25
Decision date: 1998-03-11
Decision: Unknown
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MJN

product code MJN

Death: 31
Injury: 240
Malfunction: 827
Total: 1,098

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.