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FDA 510(k)

RADIUS PTCA GUIDEWIRE

K-Number: K970466 · 1997-05-20

ApplicantRadius Medical Technologies, Inc.
Decision Date1997-05-20
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIUS PTCA 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 1997-05-20 under 510(k) number K970466. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIUS PTCA GUIDEWIRE?

RADIUS PTCA GUIDEWIRE is a medical device that received FDA 510(k) clearance on 1997-05-20. The listed applicant is Radius Medical Technologies, Inc.. The 510(k) number is K970466.

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

RADIUS PTCA GUIDEWIRE received FDA 510(k) clearance on 1997-05-20, under 510(k) number K970466.

Who is the listed applicant for RADIUS PTCA 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 PTCA GUIDEWIRE?

The FDA product code for RADIUS PTCA GUIDEWIRE is LIT.

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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.

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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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