INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER— 510(k) K911840

Name: FDA 510(k) clearance K911840
Creator: U.S. Food and Drug Administration
Published: 1991-06-03

Substantially Equivalent

Intec Medical, Inc.

FDA 510(k) clearance K911840 for INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER, Substantially Equivalent on 1991-06-03. Applicant: Intec Medical, Inc.. Device class: 2.

Clearance details

Applicant: Intec Medical, Inc.
Product code: Code DYG
Device class: Class 2
Regulation: 21 CFR 870.1240
Advisory panel: Cardiovascular
Date received: 1991-04-25
Decision date: 1991-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, VA, US

Download summary PDF View on FDA.gov ↗

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K903840 — GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSY1990-10-16
K903906 — PERCUTANEOUS CATHETER INTRODUCER KIT1990-09-26

Adverse events under product code DYG

product code DYG

Death: 18
Malfunction: 1,051
Other: 1
Total: 1,070

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.