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FDA 510(k)

RADIA STEERABLE DIAGNOSTIC CATHETER

K-Number: K091370 · 2009-06-05

ApplicantC.R. Bard, Inc.
Decision Date2009-06-05
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIA STEERABLE DIAGNOSTIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2009-06-05 under 510(k) number K091370. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIA STEERABLE DIAGNOSTIC CATHETER?

RADIA STEERABLE DIAGNOSTIC CATHETER is a medical device that received FDA 510(k) clearance on 2009-06-05. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K091370.

When did RADIA STEERABLE DIAGNOSTIC CATHETER receive FDA 510(k) clearance?

RADIA STEERABLE DIAGNOSTIC CATHETER received FDA 510(k) clearance on 2009-06-05, under 510(k) number K091370.

Who is the listed applicant for RADIA STEERABLE DIAGNOSTIC CATHETER?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIA STEERABLE DIAGNOSTIC CATHETER?

The FDA product code for RADIA STEERABLE DIAGNOSTIC CATHETER is DRF.

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Related Devices (Code: DRF)

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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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