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FDA 510(k)

PRUITT CAROTID KIT

K-Number: K103356 · 2010-12-08

ApplicantLeMaitre Vascular, Inc.
Decision Date2010-12-08
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRUITT CAROTID KIT is the device name listed in this FDA 510(k) record. The listed applicant is LeMaitre Vascular, Inc.. It received FDA 510(k) clearance on 2010-12-08 under 510(k) number K103356. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRUITT CAROTID KIT?

PRUITT CAROTID KIT is a medical device that received FDA 510(k) clearance on 2010-12-08. The listed applicant is LeMaitre Vascular, Inc.. The 510(k) number is K103356.

When did PRUITT CAROTID KIT receive FDA 510(k) clearance?

PRUITT CAROTID KIT received FDA 510(k) clearance on 2010-12-08, under 510(k) number K103356.

Who is the listed applicant for PRUITT CAROTID KIT?

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

What is the FDA product code for PRUITT CAROTID KIT?

The FDA product code for PRUITT CAROTID KIT is MJN.

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Other records listing LeMaitre Vascular, Inc. as applicant

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Related Devices (Code: MJN)

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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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