SCIMED GATEWAY PLUS— 510(k) K951089

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K951089 for SCIMED GATEWAY PLUS, Substantially Equivalent on 1995-05-31. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 1995-03-09
Decision date: 1995-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.