PVS 1400 GUIDEWIRE— 510(k) K990823

Name: FDA 510(k) clearance K990823
Creator: U.S. Food and Drug Administration
Published: 1999-07-23

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.. Device class: 2.

Clearance details

Applicant: Precision Vascular Systems, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
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 ↗

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More clearances from Precision Vascular Systems, Inc.

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K032494 — PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER2003-09-05
K032146 — PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES2003-08-12
K023700 — PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE2002-12-04
K020733 — PVS 1500 SDS2002-03-21
K002907 — PVS 1300 NEURO GUIDE WIRE2001-03-08

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.