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FDA 510(k)

AcuNav Diagnostic Ultrasound Catheter 8F,10F

K-Number: K170263 · 2017-06-15

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-06-15
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcuNav Diagnostic Ultrasound Catheter 8F,10F is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K170263. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcuNav Diagnostic Ultrasound Catheter 8F,10F?

AcuNav Diagnostic Ultrasound Catheter 8F,10F is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K170263.

When did AcuNav Diagnostic Ultrasound Catheter 8F,10F receive FDA 510(k) clearance?

AcuNav Diagnostic Ultrasound Catheter 8F,10F received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170263.

Who is the listed applicant for AcuNav Diagnostic Ultrasound Catheter 8F,10F?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AcuNav Diagnostic Ultrasound Catheter 8F,10F?

The FDA product code for AcuNav Diagnostic Ultrasound Catheter 8F,10F is OBJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06556836"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization"COMPLETEDNCT07629427Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency DepartmentCOMPLETEDNCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Siemens Medical Solutions USA, Inc. as applicant

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Related Devices (Code: OBJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision LimitedK252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston ScientificK253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy DeviceK250955XC11 ICE System, USAYorlabs, Inc.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

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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