iLab Polaris Multi-Modality Guidance System
K-Number: K210889 · 2021-06-25
ApplicantBoston Scientific Corporation
Decision Date2021-06-25
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
iLab Polaris Multi-Modality Guidance System is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2021-06-25 under approval number K210889. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the iLab Polaris Multi-Modality Guidance System?
iLab Polaris Multi-Modality Guidance System is a medical device that received FDA 510(k) clearance on 2021-06-25. It is manufactured by Boston Scientific Corporation. The 510(k) number is K210889.
When was iLab Polaris Multi-Modality Guidance System approved by the FDA?
iLab Polaris Multi-Modality Guidance System received FDA 510(k) clearance on 2021-06-25, under approval number K210889.
What company makes iLab Polaris Multi-Modality Guidance System?
iLab Polaris Multi-Modality Guidance System is manufactured by Boston Scientific Corporation.
What is the FDA product code for iLab Polaris Multi-Modality Guidance System?
The FDA product code for iLab Polaris Multi-Modality Guidance System is DQK.
Related Clinical Trials
NCT07191067
Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty
RECRUITING
NCT06011187
Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery
COMPLETED
NCT07458243
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
NOT_YET_RECRUITING
NCT06735534
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
RECRUITING
NCT05508360
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
RECRUITING
NCT06578104
PULSED AF Post-Approval Study
RECRUITING
Related PubMed Literature
PMID: 42175114
Make Open Source Compliant: Validation in Non-Interventional Clinical Studies.
Studies in health technology and informatics (2026)
PMID: 42168293
Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling.
Scientific reports (2026)
PMID: 41887630
Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa.
BMJ open (2026)
PMID: 40775863
Use of the Learning Health System to Redesign and Implement a Clinical Decision Support System for Antimicrobial Stewardship.
Studies in health technology and informatics (2025)
Other Devices by Boston Scientific Corporation
K163200Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete
K163174Emerge PTCA Dilatation Catheter
K162350Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018
K162404Express SD Biliary Monorail Premounted Stent System
K160823NC Quantum Apex PTCA Dilatation Catheter
K160514OptiCross 18, 30 MHz Peripheral Imaging Catheter
Related Devices (Code: DQK)
K160218AutoMark ModuleSt Jude Medical
K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical
K162643MediGuide Technology SystemSt Jude Medical
K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.
K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical
K160186EnSite Velocity Surface Electrode KitSt Jude Medical
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.