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FDA 510(k)

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)

K-Number: K090040 · 2009-02-06

ApplicantTerumo Medical Corp.
Decision Date2009-02-06
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K090040. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)?

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Terumo Medical Corp.. The 510(k) number is K090040.

When did RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) receive FDA 510(k) clearance?

RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) received FDA 510(k) clearance on 2009-02-06, under 510(k) number K090040.

Who is the listed applicant for RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)?

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

What is the FDA product code for RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)?

The FDA product code for RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) is DQO.

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Other records listing Terumo Medical Corp. as applicant

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Related Devices (Code: DQO)

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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