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FDA 510(k)

PULSIOFLEX

K-Number: K112448 · 2011-09-22

ApplicantPulsion Medical Systems, Inc.
Decision Date2011-09-22
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSIOFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Pulsion Medical Systems, Inc.. It received FDA 510(k) clearance on 2011-09-22 under 510(k) number K112448. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSIOFLEX?

PULSIOFLEX is a medical device that received FDA 510(k) clearance on 2011-09-22. The listed applicant is Pulsion Medical Systems, Inc.. The 510(k) number is K112448.

When did PULSIOFLEX receive FDA 510(k) clearance?

PULSIOFLEX received FDA 510(k) clearance on 2011-09-22, under 510(k) number K112448.

Who is the listed applicant for PULSIOFLEX?

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

What is the FDA product code for PULSIOFLEX?

The FDA product code for PULSIOFLEX is DXG.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pulsion Medical 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.

K001762PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEMK991886PULSION PULSIOCATH, PULSION PCCO MONITORING KIT, PULSION IN-LINE INJECTATE SENSOR

Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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