Bresagen Catheter, Model CS-3000

FDA 510(k) K021481 · Bresagen, Inc.

Substantially Equivalent

510(k) numberK021481

Submission

Device name
Bresagen Catheter, Model CS-3000
Applicant
Bresagen, Inc.
Athens, GA, US
Received
May 8, 2002
Decision date
August 6, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HCA – Catheter, Ventricular
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4100
Specialty
Neurology

Other 510(k)s with product code HCA

510(k)DeviceApplicantDecision
K161731Cleveland Multiport Ventricular Catheter SetHCA · Traditional Parker Hannifin Corp.03/27/2017SE
K123605Smartflow CatheterHCA · Traditional Mri Interventions, Inc.08/16/2013SE
K031123Codman Bactiseal Barium Striped CathetersHCA · Special Codman & Shurtleff, Inc.05/14/2003SE
K020728Miethke Shunt SystemHCA · Special Aesculap, Inc.04/05/2002SE
K013005Act 11 MP Ventricular CatheterHCA · Traditional Innerspace, Inc.03/08/2002SE
K003322Codman Bactiseal CathetersHCA · Traditional Codman & Shurtleff, Inc.10/01/2001SE
K992796Aspiration/Irrigation Catheter, Model AC-1000HCA · Traditional Image-Guided Neurologics, Inc.10/25/1999SE
K983331Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional Medtronic PS Medical12/16/1998SE
K834477Dispos. Scott Cannulas 16-1054 Etc.HCA · Traditional Codman & Shurtleff, Inc.03/19/1984SE

Questions and answers

When was Bresagen Catheter, Model CS-3000 cleared by the FDA?

Bresagen Catheter, Model CS-3000 (K021481) received a 510(k) decision of Substantially Equivalent on August 6, 2002, 90 days after the submission was received.

What is the product code of K021481?

The FDA product code is HCA – Catheter, Ventricular, a Class II (moderate risk) device regulated under 21 CFR 882.4100.