Atlas FDA

ILUMIEN System with AptiVue Software version D.3

FDA 510(k) clearance K192267 · decided 2019-12-17

Clearance details

K-number
K192267
Device name
ILUMIEN System with AptiVue Software version D.3
Applicant
ABBOTT MEDICAL
Decision
Substantially Equivalent
Date received
2019-08-21
Decision date
2019-12-17
Days to decision
118 days
Clearance type
Special
Product code
DQO
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Westford, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch ABBOTT MEDICAL

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Arterial Pressure Monitoring Set/Tray (K261455)Spectrum Vascular2026-06-26
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N (K252702)Bioptimal International Pte. , Ltd.2026-05-28
Arterial Pressure Monitoring Set/Tray (K254278)Spectrum Vascular2026-03-25
DualView Catheter (K250751)Terumo Corporation2025-07-17
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (K242966)Gentuity, LLC2025-01-31
pNOVUS 21 Microcatheter (K242420)Phenox, Ltd.2024-11-12
Impress Angiographic Catheter (K233268)Merit Medical Systems, Inc.2024-05-22
Zoom 6F Insert Catheters (K233975)Imperative Care, Inc.2024-04-02
Soldier Microcatheter (K232536)Embolx, Inc.2024-02-23
INFINITI™ Ambi Angiographic Catheter (K232573)Cordis US Corp2023-11-21
Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K230620)Gentuity, LLC2023-08-08
Drakon™ and Sequre® Microcatheters (K231293)Accurate Medical Therapeutics2023-06-01

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Proclaim Dorsal Root Ganglion (DRG) System (P150004/S092)ABBOTT MEDICAL2025-12-23
Proclaim™ Spinal Cord Stimulation (SCS) System (P010032/S246)ABBOTT MEDICAL2025-12-23
Infinity™ Deep Brain Stimulation (DBS) System (P140009/S127)ABBOTT MEDICAL2025-12-23
Amplatzer™ Amulet™ Left Atrial Appendage Occluder (P200049/S014)ABBOTT MEDICAL2025-12-23
Volt™ PFA System (P250022)ABBOTT MEDICAL2025-12-19
HeartMate II™ Left Ventricular Assist System (P060040/S122)ABBOTT MEDICAL2025-12-17
HeartMate 3™ Left Ventricular Assist System (P160054/S116)ABBOTT MEDICAL2025-12-17
Durata Leads; Optisure Leads (P950022/S151)ABBOTT MEDICAL2025-12-09