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FDA 510(k)

NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER

K-Number: K090918 · 2009-07-30

ApplicantNfocus Neuromedical, Inc.
Decision Date2009-07-30
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Nfocus Neuromedical, Inc.. It received FDA 510(k) clearance on 2009-07-30 under 510(k) number K090918. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER?

NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER is a medical device that received FDA 510(k) clearance on 2009-07-30. The listed applicant is Nfocus Neuromedical, Inc.. The 510(k) number is K090918.

When did NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER receive FDA 510(k) clearance?

NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER received FDA 510(k) clearance on 2009-07-30, under 510(k) number K090918.

Who is the listed applicant for NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER?

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

What is the FDA product code for NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER?

The FDA product code for NFOCUS NEUROMEDICAL ECHO DISTAL ACCESS CATHETER is DQY.

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Other records listing Nfocus Neuromedical, 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.

K091952ACTA VESSEL OCCLUSION SYSTEM (VOS)

Related Devices (Code: DQY)

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.

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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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