THE V-BAG— 510(k) K001822

Substantially Equivalent

Circulatory Technology, Inc.

FDA 510(k) clearance K001822 for THE V-BAG, Substantially Equivalent on 2000-07-07. Applicant: Circulatory Technology, Inc..

Clearance details

Applicant: Circulatory Technology, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2000-06-16
Decision date: 2000-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oyster Bay, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.