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FDA 510(k)

MANAN GWI GUIDE WIRE INTRODUCER

K-Number: K974745 · 1998-04-06

ApplicantMedical Device Technologies, Inc.
Decision Date1998-04-06
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MANAN GWI GUIDE WIRE INTRODUCER 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 1998-04-06 under 510(k) number K974745. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN GWI GUIDE WIRE INTRODUCER?

MANAN GWI GUIDE WIRE INTRODUCER is a medical device that received FDA 510(k) clearance on 1998-04-06. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K974745.

When did MANAN GWI GUIDE WIRE INTRODUCER receive FDA 510(k) clearance?

MANAN GWI GUIDE WIRE INTRODUCER received FDA 510(k) clearance on 1998-04-06, under 510(k) number K974745.

Who is the listed applicant for MANAN GWI GUIDE WIRE INTRODUCER?

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 GWI GUIDE WIRE INTRODUCER?

The FDA product code for MANAN GWI GUIDE WIRE INTRODUCER is DRC.

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Other records listing Medical Device Technologies, Inc. as applicant

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K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENTK053518INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK050873CANALIZER HYDROPHILIC GUIDE WIREK043523INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLEK042464V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

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Related Devices (Code: DRC)

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.

K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical CorporationK241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLCK221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLCK212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLCK172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC

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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