IVR-SP CUSTOM ANGIOGRAPHY TRAY— 510(k) K870419

Substantially Equivalent

North Coast Medi-Tek

FDA 510(k) clearance K870419 for IVR-SP CUSTOM ANGIOGRAPHY TRAY, Substantially Equivalent on 1987-05-11. Applicant: North Coast Medi-Tek.

Clearance details

Applicant: North Coast Medi-Tek
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 1987-02-03
Decision date: 1987-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQO

product code DQO

Death: 35
Injury: 993
Malfunction: 1,772
Other: 5
Total: 2,805

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.