FDA 510(k)

MANAN GWI GUIDE WIRE INTRODUCER

K-Number: K851834 · 1985-07-11

Decision Date1985-07-11

Product CodeDWS

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 Manan Manufacturing Co., Inc.. It received FDA 510(k) clearance on 1985-07-11 under 510(k) number K851834. The device is classified under product code DWS. 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 1985-07-11. The listed applicant is Manan Manufacturing Co., Inc.. The 510(k) number is K851834.

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

MANAN GWI GUIDE WIRE INTRODUCER received FDA 510(k) clearance on 1985-07-11, under 510(k) number K851834.

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

The FDA 510(k) record lists Manan Manufacturing Co., 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 DWS.

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Other records listing Manan Manufacturing Co., Inc. as applicant

K873208MANAN TURNER STYLE NEEDLE K864405MANAN CONTRAST MEDIA ADMINISTRATION SET K863848MANAN BREST TUMOR LOCALIZATION NEEDLE K852501MYELOGRAM PROCEDURE TRAY K851833MANAN SELDINGER NEEDLE K851832NAMAN POTTS COURNAND NEEDLE

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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.