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FDA 510(k)

SyncVision System

K-Number: K190626 · 2019-04-12

ApplicantVolcano Corporation
Decision Date2019-04-12
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SyncVision System is a medical device manufactured by Volcano Corporation. It received FDA 510(k) clearance on 2019-04-12 under approval number K190626. 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 SyncVision System?

SyncVision System is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Volcano Corporation. The 510(k) number is K190626.

When was SyncVision System approved by the FDA?

SyncVision System received FDA 510(k) clearance on 2019-04-12, under approval number K190626.

What company makes SyncVision System?

SyncVision System is manufactured by Volcano Corporation.

What is the FDA product code for SyncVision System?

The FDA product code for SyncVision System is OWB.

Other Devices by Volcano Corporation

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip K161887Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip K161756SyncVision System K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit K172574SyncVision System K170385CORE M2 Vascular System

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Related Devices (Code: OWB)

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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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