Cleveland Multiport Ventricular Catheter Set
FDA 510(k) K161731 · Parker Hannifin Corp.
510(k) numberK161731
Submission
- Device name
- Cleveland Multiport Ventricular Catheter Set
- Applicant
- Parker Hannifin Corp.
Ventura, CA, US - Received
- June 23, 2016
- Decision date
- March 27, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K123605 | Smartflow CatheterHCA · Traditional | Mri Interventions, Inc. | 08/16/2013SE |
| K031123 | Codman Bactiseal Barium Striped CathetersHCA · Special | Codman & Shurtleff, Inc. | 05/14/2003SE |
| K021481 | Bresagen Catheter, Model CS-3000HCA · Traditional | Bresagen, Inc. | 08/06/2002SE |
| K020728 | Miethke Shunt SystemHCA · Special | Aesculap, Inc. | 04/05/2002SE |
| K013005 | Act 11 MP Ventricular CatheterHCA · Traditional | Innerspace, Inc. | 03/08/2002SE |
| K003322 | Codman Bactiseal CathetersHCA · Traditional | Codman & Shurtleff, Inc. | 10/01/2001SE |
| K992796 | Aspiration/Irrigation Catheter, Model AC-1000HCA · Traditional | Image-Guided Neurologics, Inc. | 10/25/1999SE |
| K983331 | Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional | Medtronic PS Medical | 12/16/1998SE |
| K834477 | Dispos. Scott Cannulas 16-1054 Etc.HCA · Traditional | Codman & Shurtleff, Inc. | 03/19/1984SE |
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| K897086 | Parker Ambulatory Medication Infusion Pump 2004FRN · Traditional | 09/28/1990SE |
| K863532 | Modified Labeling to Model 2000 Ambulatory InfuserFRN · Traditional | 01/14/1987SE |
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Questions and answers
When was Cleveland Multiport Ventricular Catheter Set cleared by the FDA?
Cleveland Multiport Ventricular Catheter Set (K161731) received a 510(k) decision of Substantially Equivalent on March 27, 2017, 277 days after the submission was received.
What is the product code of K161731?
The FDA product code is HCA – Catheter, Ventricular, a Class II (moderate risk) device regulated under 21 CFR 882.4100.