SCIMED ENCORE INFLATION DEVICE, MODEL SM2500— 510(k) K903503

Substantially Equivalent

Scimed

FDA 510(k) clearance K903503 for SCIMED ENCORE INFLATION DEVICE, MODEL SM2500, Substantially Equivalent on 1990-10-09. Applicant: Scimed.

Clearance details

Applicant: Scimed
Product code: Code MAV
Advisory panel: Cardiovascular
Date received: 1990-08-03
Decision date: 1990-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, 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.