PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER— 510(k) K032494

Name: FDA 510(k) clearance K032494
Creator: U.S. Food and Drug Administration
Published: 2003-09-05

Substantially Equivalent

Precision Vascular Systems, Inc.

FDA 510(k) clearance K032494 for PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER, Substantially Equivalent on 2003-09-05. Applicant: Precision Vascular Systems, Inc.. Device class: 2.

Clearance details

Applicant: Precision Vascular Systems, Inc.
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2003-08-13
Decision date: 2003-09-05
Decision: Substantially Equivalent
Clearance type: Special
Location: West Valley 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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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
K002707 — PVS 1400 GUIDE WITE WITH HYDROPHILIC COATING2000-11-08

Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

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.