RIGHT ATRIAL CATHETER KITS— 510(k) K920331

Unknown

Akcess Medical Products, Inc.

FDA 510(k) clearance K920331 for RIGHT ATRIAL CATHETER KITS, Unknown on 1992-04-22. Applicant: Akcess Medical Products, Inc..

Clearance details

Applicant: Akcess Medical Products, Inc.
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 1992-01-23
Decision date: 1992-04-22
Decision: Unknown
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.