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FDA 510(k)

LBI EMBOLECTOMY SYSTEM

K-Number: K080901 · 2008-10-02

ApplicantLumen Biomedical, Inc.
Decision Date2008-10-02
Product CodeQEW
Advisory CommitteeCV
DecisionUnknown

Device Summary

LBI EMBOLECTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lumen Biomedical, Inc.. It received FDA 510(k) clearance on 2008-10-02 under 510(k) number K080901. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the LBI EMBOLECTOMY SYSTEM?

LBI EMBOLECTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-02. The listed applicant is Lumen Biomedical, Inc.. The 510(k) number is K080901.

When did LBI EMBOLECTOMY SYSTEM receive FDA 510(k) clearance?

LBI EMBOLECTOMY SYSTEM received FDA 510(k) clearance on 2008-10-02, under 510(k) number K080901.

Who is the listed applicant for LBI EMBOLECTOMY SYSTEM?

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

What is the FDA product code for LBI EMBOLECTOMY SYSTEM?

The FDA product code for LBI EMBOLECTOMY SYSTEM is QEW.

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Other records listing Lumen Biomedical, 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.

K111987FIBERNET EMBOLIC PROTECTION DEVICEK082348FIBERNET EMBOLIC PROTECTION SYSTEMK071529XTRACT CATHETER SYSTEMK053372LBI CATHETER SYSTEM

Related Devices (Code: QEW)

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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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