FDA 510(k)

PressureWire X Guidewire

K-Number: K161171 · 2016-08-15

Decision Date2016-08-15

Product CodeDXO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PressureWire X Guidewire is a medical device manufactured by St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-08-15 under approval 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. It is manufactured by St. Jude Medical, Inc.. The 510(k) number is K161171.

When was PressureWire X Guidewire approved by the FDA?

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

What company makes PressureWire X Guidewire?

PressureWire X Guidewire is manufactured by St. Jude Medical, Inc..

What is the FDA product code for PressureWire X Guidewire?

The FDA product code for PressureWire X Guidewire is DXO.

Other Devices by St. Jude Medical, Inc.

K161102Nanostim Introducer Kit K160716The Nanostim Introducer Kit K163407Confirm Rx Insertable Cardiac Monitor (ICM) System K172393Advisor HD Grid Mapping Catheter, Sensor Enabled PMA P880006Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Related Devices (Code: DXO)

K161263OptoMonitor IIOpsens, Inc. K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K163376Mikro-Cath Pressure CatheterMillar, Inc. K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) K193279Comet II Pressure GuidewireBoston Scientific Corporation K192340OptoMonitorOpsens, 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.