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FDA 510(k)

PARADIS VASO SHIELD

K-Number: K090022 · 2009-04-20

ApplicantSpinemedica, LLC
Decision Date2009-04-20
Product CodeOMR
Advisory CommitteeCV
DecisionUnknown

Device Summary

PARADIS VASO SHIELD is the device name listed in this FDA 510(k) record. The listed applicant is Spinemedica, LLC. It received FDA 510(k) clearance on 2009-04-20 under 510(k) number K090022. The device is classified under product code OMR. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PARADIS VASO SHIELD?

PARADIS VASO SHIELD is a medical device that received FDA 510(k) clearance on 2009-04-20. The listed applicant is Spinemedica, LLC. The 510(k) number is K090022.

When did PARADIS VASO SHIELD receive FDA 510(k) clearance?

PARADIS VASO SHIELD received FDA 510(k) clearance on 2009-04-20, under 510(k) number K090022.

Who is the listed applicant for PARADIS VASO SHIELD?

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

What is the FDA product code for PARADIS VASO SHIELD?

The FDA product code for PARADIS VASO SHIELD is OMR.

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 Spinemedica, LLC 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.

K093551PARADIS VASO SHIELD

Related Devices (Code: OMR)

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.

K111048SYNTHES SCOUT TACK FIXATIONSynthes SpineK111137HYDROFIX VASO SHIELDMimedx Group, Inc.K101805HYDROFIX VASO SHIELDMimedx Group, Inc.K103558SYNTHES SCOUT VESSEL GUARDSynthes SpineK101826HYDROFIX VASO SHIELD, MODEL HVS-001-0610Mimedx Group, Inc.K100984XYLOS VESSEL GUARDXylos Corporation

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.

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