MORSE VASCULAR INTRODUCER SET— 510(k) K912961

Substantially Equivalent

North American Instrument Corp.

FDA 510(k) clearance K912961 for MORSE VASCULAR INTRODUCER SET, Substantially Equivalent on 1991-09-11. Applicant: North American Instrument Corp..

Clearance details

Applicant: North American Instrument Corp.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1991-07-08
Decision date: 1991-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glens Falls, NY, US

Download summary PDF View on FDA.gov ↗

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.