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FDA 510(k)

XYLOS VESSEL GUARD

K-Number: K100984 · 2010-07-07

ApplicantXylos Corporation
Decision Date2010-07-07
Product CodeOMR
Advisory CommitteeCV
DecisionUnknown

Device Summary

XYLOS VESSEL GUARD is the device name listed in this FDA 510(k) record. The listed applicant is Xylos Corporation. It received FDA 510(k) clearance on 2010-07-07 under 510(k) number K100984. 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 XYLOS VESSEL GUARD?

XYLOS VESSEL GUARD is a medical device that received FDA 510(k) clearance on 2010-07-07. The listed applicant is Xylos Corporation. The 510(k) number is K100984.

When did XYLOS VESSEL GUARD receive FDA 510(k) clearance?

XYLOS VESSEL GUARD received FDA 510(k) clearance on 2010-07-07, under 510(k) number K100984.

Who is the listed applicant for XYLOS VESSEL GUARD?

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

What is the FDA product code for XYLOS VESSEL GUARD?

The FDA product code for XYLOS VESSEL GUARD is OMR.

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Other records listing Xylos Corporation 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.

K111584XYLOS MACRO-POROUS SURGICAL MESHK090880XYLOS POROUS SURGICAL MESHK090778MTA PROTECTIVE SHEETK083823SECURIAN TISSUE REINFORCEMENT MATRIXK081882MODIFICATION TO XYLOS SURGICAL MESHK023237XYLOS SURGICAL MESH

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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.K100905HYDROFIX SURGICAL SHEETMimedx Group, Inc.

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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