PERCUTANEOUS SHEATH INTRODUCER TRAYS— 510(k) K833574

Name: FDA 510(k) clearance K833574
Creator: U.S. Food and Drug Administration
Published: 1984-01-11

Substantially Equivalent

Intermed, Inc.

FDA 510(k) clearance K833574 for PERCUTANEOUS SHEATH INTRODUCER TRAYS, Substantially Equivalent on 1984-01-11. Applicant: Intermed, Inc.. Device class: 2.

Clearance details

Applicant: Intermed, Inc.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1983-10-12
Decision date: 1984-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K900857 — NON STERILE PARENTERAL SUPPLY KIT1990-05-22
K842166 — INTERMED, INS STERILE WATER/SALINE1985-02-12
K833126 — DRESSING CHANGE TRAYS1984-01-27
K833573 — CENTRAL VEIN CATH. TRAY CC-20-14201984-01-11
K833139 — ACUTE HEMODIALYSIS TRAYS1983-12-22

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.