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FDA 510(k)

CPCA2000 COUNTERPULSATION SYSTEM

K-Number: K030532 · 2003-03-14

ApplicantCpca2000, Inc.
Decision Date2003-03-14
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPCA2000 COUNTERPULSATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cpca2000, Inc.. It received FDA 510(k) clearance on 2003-03-14 under 510(k) number K030532. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPCA2000 COUNTERPULSATION SYSTEM?

CPCA2000 COUNTERPULSATION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-14. The listed applicant is Cpca2000, Inc.. The 510(k) number is K030532.

When did CPCA2000 COUNTERPULSATION SYSTEM receive FDA 510(k) clearance?

CPCA2000 COUNTERPULSATION SYSTEM received FDA 510(k) clearance on 2003-03-14, under 510(k) number K030532.

Who is the listed applicant for CPCA2000 COUNTERPULSATION SYSTEM?

The FDA 510(k) record lists Cpca2000, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPCA2000 COUNTERPULSATION SYSTEM?

The FDA product code for CPCA2000 COUNTERPULSATION SYSTEM is DRN.

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Related Devices (Code: DRN)

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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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