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FDA 510(k)

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

K-Number: K202543 · 2020-09-28

ApplicantVolcano Corporation
Decision Date2020-09-28
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip is a medical device manufactured by Volcano Corporation. It received FDA 510(k) clearance on 2020-09-28 under approval number K202543. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip is a medical device that received FDA 510(k) clearance on 2020-09-28. It is manufactured by Volcano Corporation. The 510(k) number is K202543.

When was OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip approved by the FDA?

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip received FDA 510(k) clearance on 2020-09-28, under approval number K202543.

What company makes OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip is manufactured by Volcano Corporation.

What is the FDA product code for OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip?

The FDA product code for OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip is DQX.

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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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