CREATION NM DIAGNOSTIC CATHETERS— 510(k) K032888

Substantially Equivalent

Neich Medical (Shenzhen) Company Limited

FDA 510(k) clearance K032888 for CREATION NM DIAGNOSTIC CATHETERS, Substantially Equivalent on 2004-02-24. Applicant: Neich Medical (Shenzhen) Company Limited.

Clearance details

Applicant: Neich Medical (Shenzhen) Company Limited
Product code: Code DQO
Advisory panel: Cardiovascular
Date received: 2003-09-16
Decision date: 2004-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

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.