PVS 1400 GUIDEWIRE— 510(k) K990823

Substantially Equivalent

Precision Vascular Systems, Inc.

FDA 510(k) clearance K990823 for PVS 1400 GUIDEWIRE, Substantially Equivalent on 1999-07-23. Applicant: Precision Vascular Systems, Inc..

Clearance details

Applicant: Precision Vascular Systems, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1999-03-12
Decision date: 1999-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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.