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FDA 510(k)

MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177

K-Number: K892648 · 1989-05-24

ApplicantBoston Scientific Corp
Decision Date1989-05-24
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K892648. The device is classified under product code OCY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177?

MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Boston Scientific Corp. The 510(k) number is K892648.

When did MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 receive FDA 510(k) clearance?

MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 received FDA 510(k) clearance on 1989-05-24, under 510(k) number K892648.

Who is the listed applicant for MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177?

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

What is the FDA product code for MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177?

The FDA product code for MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 is OCY.

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Other records listing Boston Scientific Corp as applicant

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Related Devices (Code: OCY)

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.

K153264EasyPass GuidewireMedi-Globe CorporationK131072ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE STRAIGHT STIFF, ORCHESTRA HYDROPHILICColoplast A/SK124052OSTAVI HYDROPHILIC GUIDEWIRELake Region MedicalK123438XENX STONE MANAGEMENT DEVICEXenolith MedicalK123439NEO ERCP GUIDEWIRENeometrics, Inc.K122816AXCESS SOFT TIP WIRE GUIDEWilson-Cook Medical, 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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