PHYCON ALL SILICONE BALLOON CATHETER— 510(k) K894883

Name: FDA 510(k) clearance K894883
Creator: U.S. Food and Drug Administration
Published: 1990-04-25

Substantially Equivalent

Vitaid, Ltd.

FDA 510(k) clearance K894883 for PHYCON ALL SILICONE BALLOON CATHETER, Substantially Equivalent on 1990-04-25. Applicant: Vitaid, Ltd.. Device class: 2.

Clearance details

Applicant: Vitaid, Ltd.
Product code: Code EZL
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1989-08-01
Decision date: 1990-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code EZL

view all

K260756 — TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)2026-09-04
K262056 — Rusch Latex Gold Foley Catheter2026-08-05
K252537 — Rusch SoftSimplastic Foley Catheters2026-01-20
K243011 — Silicone Urethral Catheter (Silicone Urethral Catheter)2025-06-16
K241424 — InnoCare Specialty Foley Catheter2024-09-18

More clearances from Vitaid, Ltd.

view all

K050803 — PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES2005-06-30
K932647 — WIRE REINFORCED ENDOTRACHEAL TUBE1993-11-02
K901738 — SELFCATH1990-06-27
K894794 — AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP1989-11-21
K894669 — LASER SHIELDING TUBE1989-10-13

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

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.