REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS— 510(k) K092896

Substantially Equivalent

Nemoto Kyorindo Co., Ltd.

FDA 510(k) clearance K092896 for REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS, Substantially Equivalent on 2010-10-29. Applicant: Nemoto Kyorindo Co., Ltd..

Clearance details

Applicant: Nemoto Kyorindo Co., Ltd.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 2009-09-21
Decision date: 2010-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kawaguchi-Shi, Saitama, JP

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.