SCHNEIDER-SHILEY GUIDE WIRE— 510(k) K864787

Name: FDA 510(k) clearance K864787
Creator: U.S. Food and Drug Administration
Published: 1987-02-19

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K864787 for SCHNEIDER-SHILEY GUIDE WIRE, Substantially Equivalent on 1987-02-19. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1986-12-08
Decision date: 1987-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

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K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR12001991-08-09
K910923 — BCD ADVANCED1991-04-09
K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS1991-01-14

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.