SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT)— 510(k) K900753

Name: FDA 510(k) clearance K900753
Creator: U.S. Food and Drug Administration
Published: 1990-04-10

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K900753 for SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT), Substantially Equivalent on 1990-04-10. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code DWF
Device class: Class 2
Regulation: 21 CFR 870.4210
Advisory panel: Cardiovascular
Date received: 1990-02-16
Decision date: 1990-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K253203 — Retrograde Coronary Sinus Perfusion Cannulae2026-02-19
K253671 — Dual Stage Venous Cannulae2026-01-30

More clearances from Shiley, Inc.

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K920594 — SHILEY PERFUSION TUBING SETS1993-03-18
K910991 — SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM1991-11-27
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 DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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 →

Recalls naming K900753

K-number listed on FDA's recall record

Z-2463-2020 — Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091Class II·Terminated·LivaNova USA Inc.·20200424
Z-2464-2020 — Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107Class II·Terminated·LivaNova USA Inc.·20200424

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K900753.

Data sourced from openFDA. This site is unofficial and independent of the FDA.