PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE— 510(k) K030617

Substantially Equivalent

Boston Scientific Scimed, Inc.

FDA 510(k) clearance K030617 for PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE, Substantially Equivalent on 2003-05-21. Applicant: Boston Scientific Scimed, Inc..

Clearance details

Applicant: Boston Scientific Scimed, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2003-02-26
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Maple Grove, MN, US

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Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.