Device Listing 1219462594

Listing Summary#

Listing key: 1219462594
Premarket submission: K251211
Device: ViewFlex™ Xtra ICE Catheter; ViewFlex™ Eco Reprocessed ICE Catheter; Advisor™ HD Grid Mapping Catheter, Sensor Enabled™; Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™; Agilis™ NxT Steerable Introducer; Agilis™ NxT Steerable Introducer Dual-Reach™
Applicant: ABBOTT MEDICAL
Product code: OBJ
Decision date: 2025-05-23

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
5939	2030404	1000519796	IRVINE BIOMEDICAL. INC.	1	N	2026-01-01	2375 Morse Ave IRVINE CA US 92614
5935	2182269	2182269	St. Jude Medical, Atrial Fibrillation Division, Inc.	1	Y	2026-01-01	14901 DEVEAU PL. Minnetonka MN US 55345
161955	3005334138	3005334138	St. Jude Medical, Cardiology Division, Inc.	1	Y	2026-01-01	5050 Nathan Lane North Plymouth MN US 55442
128286	3008452825	3008452825	Barb Scherber	1	N	2026-01-01	5050 Nathan Ln N Plymouth MN US 55442
188169	3012179728	3012179728	St. Jude Medical	1	Y	2026-01-01	2305 Walnut Street Roseville MN US 55113
345182	3038966633	3038966633	Abbott Medical Mexico, S. de R.L. de C.V.	1	N	2026-01-01	Avenida FINSA 156, Lote 12 Parque Industrial FINSA III Santa Rosa Jauregui Queretaro MX C.P. 76223