SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT— 510(k) K951802

Substantially Equivalent

Scimed Life Systems, Inc.

FDA 510(k) clearance K951802 for SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT, Substantially Equivalent on 1995-07-21. Applicant: Scimed Life Systems, Inc..

Clearance details

Applicant: Scimed Life Systems, Inc.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1995-04-19
Decision date: 1995-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.