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FDA 510(k)

MANAN(TM) INTRODUCER SHEATH/NEEDLE

K-Number: K974815 · 1998-01-09

ApplicantMedical Device Technologies, Inc.
Decision Date1998-01-09
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANAN(TM) INTRODUCER SHEATH/NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1998-01-09 under 510(k) number K974815. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN(TM) INTRODUCER SHEATH/NEEDLE?

MANAN(TM) INTRODUCER SHEATH/NEEDLE is a medical device that received FDA 510(k) clearance on 1998-01-09. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K974815.

When did MANAN(TM) INTRODUCER SHEATH/NEEDLE receive FDA 510(k) clearance?

MANAN(TM) INTRODUCER SHEATH/NEEDLE received FDA 510(k) clearance on 1998-01-09, under 510(k) number K974815.

Who is the listed applicant for MANAN(TM) INTRODUCER SHEATH/NEEDLE?

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

What is the FDA product code for MANAN(TM) INTRODUCER SHEATH/NEEDLE?

The FDA product code for MANAN(TM) INTRODUCER SHEATH/NEEDLE is FGE.

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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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