Device Listing 1474675456

Listing Summary#

Listing key: 1474675456
Premarket submission: K191175
Device: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
Applicant: Acist Medical Systems, Inc.
Product code: OBJ
Decision date: 2019-06-27

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
52798	2134243	3001726808	ACIST MEDICAL SYSTEMS, INC.	1	Y	2026-01-01	7905 FULLER ROAD EDEN PRAIRIE MN US 55344