Medline Integrated Arterial Catheter

FDA 510(k) K210548 · Centurion Medical Products

Substantially Equivalent

510(k) numberK210548

Submission

Device name
Medline Integrated Arterial Catheter
Applicant
Centurion Medical Products
Williamston, MI, US
Received
February 25, 2021
Decision date
May 17, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQX – Wire, Guide, Catheter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1330
Specialty
Cardiovascular

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Questions and answers

When was Medline Integrated Arterial Catheter cleared by the FDA?

Medline Integrated Arterial Catheter (K210548) received a 510(k) decision of Substantially Equivalent on May 17, 2022, 446 days after the submission was received.

What is the product code of K210548?

The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.