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FDA 510(k)

AcuNav Volume ICE Catheter

K-Number: K163478 · 2017-02-09

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-02-09
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcuNav Volume ICE Catheter is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-02-09 under approval number K163478. 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 Volume ICE Catheter?

AcuNav Volume ICE Catheter is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K163478.

When was AcuNav Volume ICE Catheter approved by the FDA?

AcuNav Volume ICE Catheter received FDA 510(k) clearance on 2017-02-09, under approval number K163478.

What company makes AcuNav Volume ICE Catheter?

AcuNav Volume ICE Catheter is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for AcuNav Volume ICE Catheter?

The FDA product code for AcuNav Volume ICE Catheter is OBJ.

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Related Devices (Code: 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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