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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 a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-06-15 under approval 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. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K170263.

When was AcuNav Diagnostic Ultrasound Catheter 8F,10F approved by the FDA?

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

What company makes AcuNav Diagnostic Ultrasound Catheter 8F,10F?

AcuNav Diagnostic Ultrasound Catheter 8F,10F is manufactured by Siemens Medical Solutions USA, Inc..

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.

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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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