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FDA 510(k)

RADIUS NEXT GENERATION GUIDEWIRE

K-Number: K011759 · 2001-08-23

ApplicantRadius Medical Technologies, Inc.
Decision Date2001-08-23
Product CodeOCY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RADIUS NEXT GENERATION GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Radius Medical Technologies, Inc.. It received FDA 510(k) clearance on 2001-08-23 under 510(k) number K011759. 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 RADIUS NEXT GENERATION GUIDEWIRE?

RADIUS NEXT GENERATION GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2001-08-23. The listed applicant is Radius Medical Technologies, Inc.. The 510(k) number is K011759.

When did RADIUS NEXT GENERATION GUIDEWIRE receive FDA 510(k) clearance?

RADIUS NEXT GENERATION GUIDEWIRE received FDA 510(k) clearance on 2001-08-23, under 510(k) number K011759.

Who is the listed applicant for RADIUS NEXT GENERATION GUIDEWIRE?

The FDA 510(k) record lists Radius Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIUS NEXT GENERATION GUIDEWIRE?

The FDA product code for RADIUS NEXT GENERATION GUIDEWIRE is OCY.

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Other records listing Radius Medical Technologies, Inc. as applicant

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.

K070502RADIUS SNAREK071457MODIFICATION TO RADIUS SNAREK032899RADIUS COUGAR WIREK032129RADIUS 018 COUGAR WIREK022201RADIUS MICRO SNAREK021441RADIUS SNARE

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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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