SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM— 510(k) K913746

Name: FDA 510(k) clearance K913746
Creator: U.S. Food and Drug Administration
Published: 1991-12-17

Substantially Equivalent

Peripheral Systems Group

FDA 510(k) clearance K913746 for SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEM, Substantially Equivalent on 1991-12-17. Applicant: Peripheral Systems Group. Device class: 2.

Clearance details

Applicant: Peripheral Systems Group
Product code: Code ITX
Device class: Class 2
Regulation: 21 CFR 892.1570
Advisory panel: Radiology
Date received: 1991-08-21
Decision date: 1991-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.