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FDA 510(k)

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054

K-Number: K100518 · 2010-08-31

ApplicantInstrumed International, Inc.
Decision Date2010-08-31
Product CodeDWP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumed International, Inc.. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K100518. The device is classified under product code DWP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054?

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Instrumed International, Inc.. The 510(k) number is K100518.

When did INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 receive FDA 510(k) clearance?

INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 received FDA 510(k) clearance on 2010-08-31, under 510(k) number K100518.

Who is the listed applicant for INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054?

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

What is the FDA product code for INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054?

The FDA product code for INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 is DWP.

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Other records listing Instrumed International, 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.

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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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