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FDA 510(k)

Comet II Pressure Guidewire

K-Number: K193279 · 2019-12-23

ApplicantBoston Scientific Corporation
Decision Date2019-12-23
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Comet II Pressure Guidewire is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-12-23 under approval number K193279. 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 Comet II Pressure Guidewire?

Comet II Pressure Guidewire is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K193279.

When was Comet II Pressure Guidewire approved by the FDA?

Comet II Pressure Guidewire received FDA 510(k) clearance on 2019-12-23, under approval number K193279.

What company makes Comet II Pressure Guidewire?

Comet II Pressure Guidewire is manufactured by Boston Scientific Corporation.

What is the FDA product code for Comet II Pressure Guidewire?

The FDA product code for Comet II Pressure Guidewire is DXO.

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Related Devices (Code: DXO)

K161263OptoMonitor IIOpsens, Inc. K161171PressureWire X GuidewireSt. Jude Medical, Inc. K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K163376Mikro-Cath Pressure CatheterMillar, Inc. K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) 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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