Medcomp Vessel Dilator— 510(k) K162389

Substantially Equivalent

Medcomp ( Medical Components)

FDA 510(k) clearance K162389 for Medcomp Vessel Dilator, Substantially Equivalent on 2017-06-01. Applicant: Medcomp ( Medical Components).

Clearance details

Applicant: Medcomp ( Medical Components)
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2016-08-26
Decision date: 2017-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Harleysville, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.