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FDA 510(k)

LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES

K-Number: K083091 · 2008-12-24

ApplicantBiocompatibles UK Limited
Decision Date2008-12-24
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES is the device name listed in this FDA 510(k) record. The listed applicant is Biocompatibles UK Limited. It received FDA 510(k) clearance on 2008-12-24 under 510(k) number K083091. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES?

LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES is a medical device that received FDA 510(k) clearance on 2008-12-24. The listed applicant is Biocompatibles UK Limited. The 510(k) number is K083091.

When did LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES receive FDA 510(k) clearance?

LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES received FDA 510(k) clearance on 2008-12-24, under 510(k) number K083091.

Who is the listed applicant for LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES?

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

What is the FDA product code for LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES?

The FDA product code for LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES is KRD.

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Other records listing Biocompatibles UK Limited 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.

K162373LC Bead LUMIK094018LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERESK042231GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERESK033761GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES

Related Devices (Code: KRD)

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.

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific CorporationK261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

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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