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FDA 510(k)

BRESAGEN CATHETER, MODEL CS-3000

K-Number: K021481 · 2002-08-06

ApplicantBresagen, Inc.
Decision Date2002-08-06
Product CodeHCA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BRESAGEN CATHETER, MODEL CS-3000 is the device name listed in this FDA 510(k) record. The listed applicant is Bresagen, Inc.. It received FDA 510(k) clearance on 2002-08-06 under 510(k) number K021481. The device is classified under product code HCA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRESAGEN CATHETER, MODEL CS-3000?

BRESAGEN CATHETER, MODEL CS-3000 is a medical device that received FDA 510(k) clearance on 2002-08-06. The listed applicant is Bresagen, Inc.. The 510(k) number is K021481.

When did BRESAGEN CATHETER, MODEL CS-3000 receive FDA 510(k) clearance?

BRESAGEN CATHETER, MODEL CS-3000 received FDA 510(k) clearance on 2002-08-06, under 510(k) number K021481.

Who is the listed applicant for BRESAGEN CATHETER, MODEL CS-3000?

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

What is the FDA product code for BRESAGEN CATHETER, MODEL CS-3000?

The FDA product code for BRESAGEN CATHETER, MODEL CS-3000 is HCA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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