ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH— 510(k) K883763

Name: FDA 510(k) clearance K883763
Creator: U.S. Food and Drug Administration
Published: 1988-11-18

Substantially Equivalent

Acme-Monaco Corp.

FDA 510(k) clearance K883763 for ACME GUIDEWIRES FOR PERCUTANEOUS INSERTION OF CATH, Substantially Equivalent on 1988-11-18. Applicant: Acme-Monaco Corp.. Device class: 2.

Clearance details

Applicant: Acme-Monaco Corp.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1988-09-06
Decision date: 1988-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainville, CT, US

Download summary PDF View on FDA.gov ↗

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K113162 — SLIDEWIRETM(TRADEMARK PENDING)2012-07-20
K920884 — GUIDEWIRES, VARIOUS TYPES1992-08-19
K895854 — ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)1990-04-09
K895483 — ACME COATED ORTHODONTIC ARCHWIRE1990-01-29

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.