VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX— 510(k) K022257

Substantially Equivalent

Vomed Volzer Medizintechnik GmbH & Co.

FDA 510(k) clearance K022257 for VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX, Substantially Equivalent on 2002-10-04. Applicant: Vomed Volzer Medizintechnik GmbH & Co..

Clearance details

Applicant: Vomed Volzer Medizintechnik GmbH & Co.
Product code: Code DRC
Advisory panel: Cardiovascular
Date received: 2002-07-12
Decision date: 2002-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Amsterdam, Nh, NL

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRC

product code DRC

Death: 28
Injury: 412
Total: 440

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.