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FDA 510(k)

VERSAFLEX(TM) DELTA ST(TM) MONITOR

K-Number: K863922 · 1986-10-20

ApplicantVersaflex Delivery Systems, Inc.
Decision Date1986-10-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VERSAFLEX(TM) DELTA ST(TM) MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Versaflex Delivery Systems, Inc.. It received FDA 510(k) clearance on 1986-10-20 under 510(k) number K863922. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSAFLEX(TM) DELTA ST(TM) MONITOR?

VERSAFLEX(TM) DELTA ST(TM) MONITOR is a medical device that received FDA 510(k) clearance on 1986-10-20. The listed applicant is Versaflex Delivery Systems, Inc.. The 510(k) number is K863922.

When did VERSAFLEX(TM) DELTA ST(TM) MONITOR receive FDA 510(k) clearance?

VERSAFLEX(TM) DELTA ST(TM) MONITOR received FDA 510(k) clearance on 1986-10-20, under 510(k) number K863922.

Who is the listed applicant for VERSAFLEX(TM) DELTA ST(TM) MONITOR?

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

What is the FDA product code for VERSAFLEX(TM) DELTA ST(TM) MONITOR?

The FDA product code for VERSAFLEX(TM) DELTA ST(TM) MONITOR is DSH.

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 Versaflex Delivery 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.

K862937BUCHBINDER(TM) MULTIFLEX(TM) GUIDEWIRE

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., 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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