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FDA 510(k)

PVR-100/VASOGRAM

K-Number: K990123 · 1999-04-12

ApplicantVasocor, Inc.
Decision Date1999-04-12
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PVR-100/VASOGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Vasocor, Inc.. It received FDA 510(k) clearance on 1999-04-12 under 510(k) number K990123. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PVR-100/VASOGRAM?

PVR-100/VASOGRAM is a medical device that received FDA 510(k) clearance on 1999-04-12. The listed applicant is Vasocor, Inc.. The 510(k) number is K990123.

When did PVR-100/VASOGRAM receive FDA 510(k) clearance?

PVR-100/VASOGRAM received FDA 510(k) clearance on 1999-04-12, under 510(k) number K990123.

Who is the listed applicant for PVR-100/VASOGRAM?

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

What is the FDA product code for PVR-100/VASOGRAM?

The FDA product code for PVR-100/VASOGRAM is JOM.

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 Vasocor, 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.

K011625VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)K973659VASOCOR PVR 100

Related Devices (Code: JOM)

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.

K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. BiomedixK213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

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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