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FDA 510(k)

CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)

K-Number: K070490 · 2007-06-20

ApplicantAdvanced Circulatory Systems, Inc.
Decision Date2007-06-20
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) 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 2007-06-20 under 510(k) number K070490. 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 CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)?

CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) is a medical device that received FDA 510(k) clearance on 2007-06-20. The listed applicant is Advanced Circulatory Systems, Inc.. The 510(k) number is K070490.

When did CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) receive FDA 510(k) clearance?

CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) received FDA 510(k) clearance on 2007-06-20, under 510(k) number K070490.

Who is the listed applicant for CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)?

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 CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)?

The FDA product code for CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR) is BWF.

Related Clinical Trials

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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.

K040084LIFESTYLE CIRCULATORY ENHANCERK033401MODIFICATION TO RESQPOD CIRCULATORY ENHANCER

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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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