FDA 510(k)

MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K-Number: K983023 · 1998-10-01

Decision Date1998-10-01

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1998-10-01 under 510(k) number K983023. 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 MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM?

MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-10-01. The listed applicant is Cordis Corp.. The 510(k) number is K983023.

When did MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM received FDA 510(k) clearance on 1998-10-01, under 510(k) number K983023.

Who is the listed applicant for MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM?

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

What is the FDA product code for MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM?

The FDA product code for MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM is DYB.

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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.