Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VASOCOR PVR 100

K-Number: K973659 · 1997-12-17

ApplicantVasocor, Inc.
Decision Date1997-12-17
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASOCOR PVR 100 is the device name listed in this FDA 510(k) record. The listed applicant is Vasocor, Inc.. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K973659. 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 VASOCOR PVR 100?

VASOCOR PVR 100 is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Vasocor, Inc.. The 510(k) number is K973659.

When did VASOCOR PVR 100 receive FDA 510(k) clearance?

VASOCOR PVR 100 received FDA 510(k) clearance on 1997-12-17, under 510(k) number K973659.

Who is the listed applicant for VASOCOR PVR 100?

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 VASOCOR PVR 100?

The FDA product code for VASOCOR PVR 100 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)K990123PVR-100/VASOGRAM

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑