BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES— 510(k) K951307

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K951307 for BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES, Substantially Equivalent on 1995-06-22. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1995-03-22
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.