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FDA 510(k)

LIFESTYLE CIRCULATORY ENHANCER

K-Number: K040084 · 2004-04-07

ApplicantAdvanced Circulatory Systems, Inc.
Decision Date2004-04-07
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LIFESTYLE CIRCULATORY ENHANCER is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Circulatory Systems, Inc.. It received FDA 510(k) clearance on 2004-04-07 under 510(k) number K040084. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFESTYLE CIRCULATORY ENHANCER?

LIFESTYLE CIRCULATORY ENHANCER is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is Advanced Circulatory Systems, Inc.. The 510(k) number is K040084.

When did LIFESTYLE CIRCULATORY ENHANCER receive FDA 510(k) clearance?

LIFESTYLE CIRCULATORY ENHANCER received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040084.

Who is the listed applicant for LIFESTYLE CIRCULATORY ENHANCER?

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

What is the FDA product code for LIFESTYLE CIRCULATORY ENHANCER?

The FDA product code for LIFESTYLE CIRCULATORY ENHANCER is BWF.

Related Clinical Trials

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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Other records listing Advanced Circulatory Systems, Inc. as applicant

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.

K070490CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)K033401MODIFICATION TO RESQPOD CIRCULATORY ENHANCER

Related Devices (Code: BWF)

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

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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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