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FDA 510(k)

PressureWire X Guidewire

K-Number: K161171 · 2016-08-15

ApplicantSt. Jude Medical, Inc.
Decision Date2016-08-15
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PressureWire X Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-08-15 under 510(k) number K161171. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PressureWire X Guidewire?

PressureWire X Guidewire is a medical device that received FDA 510(k) clearance on 2016-08-15. The listed applicant is St. Jude Medical, Inc.. The 510(k) number is K161171.

When did PressureWire X Guidewire receive FDA 510(k) clearance?

PressureWire X Guidewire received FDA 510(k) clearance on 2016-08-15, under 510(k) number K161171.

Who is the listed applicant for PressureWire X Guidewire?

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

What is the FDA product code for PressureWire X Guidewire?

The FDA product code for PressureWire X Guidewire is DXO.

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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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