10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE— 510(k) K922573

Substantially Equivalent

Boston Scientific Corp

FDA 510(k) clearance K922573 for 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE, Substantially Equivalent on 1992-12-08. Applicant: Boston Scientific Corp.

Clearance details

Applicant: Boston Scientific Corp
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1992-06-01
Decision date: 1992-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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Adverse events under product code MAV

product code MAV

Malfunction: 1,433
Total: 1,433

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.