FDA 510(k), K213854, SavvyWire

510(K) Number: K213854
Device Name: SavvyWire
Manufacturer: Opsens Inc.
Device Classification Name: Wire, Guide, Catheter
Regulation Number: 870.1330
Classification Product Code: DQX
Date Received: 12/10/2021
Decision Date: 09/14/2022
Regulation Medical Specialty: Cardiovascular

861 pages (6,468 of the original 7,329 were fully redacted)