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FDA 510(k)

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010

K-Number: K101194 · 2011-07-11

ApplicantCarticept Medical, Inc.
Decision Date2011-07-11
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 is the device name listed in this FDA 510(k) record. The listed applicant is Carticept Medical, Inc.. It received FDA 510(k) clearance on 2011-07-11 under 510(k) number K101194. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010?

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 is a medical device that received FDA 510(k) clearance on 2011-07-11. The listed applicant is Carticept Medical, Inc.. The 510(k) number is K101194.

When did NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 receive FDA 510(k) clearance?

NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 received FDA 510(k) clearance on 2011-07-11, under 510(k) number K101194.

Who is the listed applicant for NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010?

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

What is the FDA product code for NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010?

The FDA product code for NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010 is FRN.

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.

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Other records listing Carticept Medical, 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.

K124053NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)K122215NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)K120830NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)K112067NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS)

Related Devices (Code: FRN)

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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