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FDA 510(k)

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD

K-Number: K243432 · 2025-07-22

ApplicantBrainlab AG
Decision Date2025-07-22
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is a medical device manufactured by Brainlab AG. It received FDA 510(k) clearance on 2025-07-22 under approval number K243432. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is a medical device that received FDA 510(k) clearance on 2025-07-22. It is manufactured by Brainlab AG. The 510(k) number is K243432.

When was Vascular Navigation PAD 2.0; Navigation Software Vascular PAD approved by the FDA?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD received FDA 510(k) clearance on 2025-07-22, under approval number K243432.

What company makes Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is manufactured by Brainlab AG.

What is the FDA product code for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD?

The FDA product code for Vascular Navigation PAD 2.0; Navigation Software Vascular PAD is OWB.

Related Clinical Trials

NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06588543 Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping RECRUITING NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07384741 Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients ACTIVE_NOT_RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT07492862 Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder NOT_YET_RECRUITING

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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.

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