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FDA 510(k)

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

K-Number: K080425 · 2008-04-23

ApplicantBiosense Webster, Inc.
Decision Date2008-04-23
Product CodeDRF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 is the device name listed in this FDA 510(k) record. The listed applicant is Biosense Webster, Inc.. It received FDA 510(k) clearance on 2008-04-23 under 510(k) number K080425. 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 CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02?

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 is a medical device that received FDA 510(k) clearance on 2008-04-23. The listed applicant is Biosense Webster, Inc.. The 510(k) number is K080425.

When did CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 receive FDA 510(k) clearance?

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 received FDA 510(k) clearance on 2008-04-23, under 510(k) number K080425.

Who is the listed applicant for CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02?

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

What is the FDA product code for CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02?

The FDA product code for CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 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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