Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 1222117.
Violations0
Issue DateFeb 4, 2020
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Unetixs Vascular, Inc.
Location
United States
FEI Number
1222117
Country
United States
Issue Date
February 04, 2020
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Based on limited metadata, Unetixs Vascular, Inc. received an FDA Warning Letter on February 4, 2020, regarding medical devices. Without access to the full letter text or specific subject line, the precise nature of the violations cannot be determined from the available information. The warning falls under FDA medical device regulation, though the specific issuing office and violation count are not documented in this metadata summary.
Unetixs Vascular, Inc. FDA Warning Letter, February 4, 2020