Cordis BRITECROSS Support Catheter

FDA 510(k) K233637 · Cordis US Corp

Substantially Equivalent

510(k) numberK233637

Submission

Device name
Cordis BRITECROSS Support Catheter
Applicant
Cordis US Corp
Miami Lakes, FL, US
Received
November 13, 2023
Decision date
June 28, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQY – Catheter, Percutaneous
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1250
Specialty
Cardiovascular

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Questions and answers

When was Cordis BRITECROSS Support Catheter cleared by the FDA?

Cordis BRITECROSS Support Catheter (K233637) received a 510(k) decision of Substantially Equivalent on June 28, 2024, 228 days after the submission was received.

What is the product code of K233637?

The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.