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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 the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-12-23 under 510(k) 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. The listed applicant is Boston Scientific Corporation. The 510(k) number is K193279.

When did Comet II Pressure Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for Comet II Pressure Guidewire?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

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)

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, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, 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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