PTFE Super Sheath Introducer 2.1— 510(k) K153246

Name: FDA 510(k) clearance K153246
Creator: U.S. Food and Drug Administration
Published: 2016-02-12

Substantially Equivalent

Medcomp (Medical Components, Inc.)

FDA 510(k) clearance K153246 for PTFE Super Sheath Introducer 2.1, Substantially Equivalent on 2016-02-12. Applicant: Medcomp (Medical Components, Inc.). Device class: 2.

Clearance details

Applicant: Medcomp (Medical Components, Inc.)
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 2015-11-09
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.