FDA 510(k) Applications Submitted by Balt USA, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K230609 03/06/2023 NG Delivery Catheter Balt USA, LLC
K202366 08/19/2020 MAGIC Infusion Catheter Balt USA, LLC
K223386 11/07/2022 Optima Coil System Balt USA, LLC
K200030 01/07/2020 Optima Coil System Balt USA, LLC
K182337 08/28/2018 HYBRID Guidewire Balt USA, LLC
K183045 11/02/2018 Eclipse 2L Balt USA, LLC
K213435 10/22/2021 MAGIC Flow-Dependent Microcatheter Balt USA, LLC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact