FDA 510(k)

PressureWire X

K-Number: K180558 · 2018-03-28

ApplicantSt. Jude Medical (Now Part of Abbott Medical)

Decision Date2018-03-28

Product CodeDXO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PressureWire X is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical (Now Part of Abbott Medical). It received FDA 510(k) clearance on 2018-03-28 under 510(k) number K180558. 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?

PressureWire X is a medical device that received FDA 510(k) clearance on 2018-03-28. The listed applicant is St. Jude Medical (Now Part of Abbott Medical). The 510(k) number is K180558.

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

PressureWire X received FDA 510(k) clearance on 2018-03-28, under 510(k) number K180558.

Who is the listed applicant for PressureWire X?

The FDA 510(k) record lists St. Jude Medical (Now Part of Abbott Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PressureWire X?

The FDA product code for PressureWire X is DXO.

Related Devices (Code: DXO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.