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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 a medical device manufactured by St. Jude Medical (Now Part of Abbott Medical). It received FDA 510(k) clearance on 2018-03-28 under approval 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. It is manufactured by St. Jude Medical (Now Part of Abbott Medical). The 510(k) number is K180558.

When was PressureWire X approved by the FDA?

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

What company makes PressureWire X?

PressureWire X is manufactured by St. Jude Medical (Now Part of Abbott Medical).

What is the FDA product code for PressureWire X?

The FDA product code for PressureWire X is DXO.

Related Devices (Code: DXO)

K161263OptoMonitor IIOpsens, Inc. K161171PressureWire X GuidewireSt. Jude Medical, Inc. K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K163376Mikro-Cath Pressure CatheterMillar, Inc. K193279Comet II Pressure GuidewireBoston Scientific Corporation K192340OptoMonitorOpsens, Inc.

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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