FDA 510(k)

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX

K-Number: K002847 · 2001-05-31

Decision Date2001-05-31

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX is the device name listed in this FDA 510(k) record. The listed applicant is Maxxim Medical. It received FDA 510(k) clearance on 2001-05-31 under 510(k) number K002847. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX?

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX is a medical device that received FDA 510(k) clearance on 2001-05-31. The listed applicant is Maxxim Medical. The 510(k) number is K002847.

When did INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX receive FDA 510(k) clearance?

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX received FDA 510(k) clearance on 2001-05-31, under 510(k) number K002847.

Who is the listed applicant for INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX?

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

What is the FDA product code for INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX?

The FDA product code for INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX is DYB.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.