Codman Bactiseal Catheters
FDA 510(k) K003322 · Codman & Shurtleff, Inc.
510(k) numberK003322
Submission
- Device name
- Codman Bactiseal Catheters
- Applicant
- Codman & Shurtleff, Inc.
Raynham, MA, US - Received
- October 24, 2000
- Decision date
- October 1, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter SetHCA · Traditional | Parker Hannifin Corp. | 03/27/2017SE |
| 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 |
| 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 |
More from Codman & Shurtleff, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K193380 | CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing SetNRY · Traditional | 07/20/2020SE |
| K191237 | CERENOVUS Large Bore CatheterDQY · Traditional | 11/08/2019SE |
| K173192 | CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP…GWM · Special | 11/08/2017SE |
| K172537 | Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System…JXG · Traditional | 10/16/2017SE |
| K172022 | CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)JXG · Traditional | 10/03/2017SE |
| K171862 | GALAXY G3 Mini Microcoil Delivery SystemHCG · Traditional | 09/25/2017SE |
| K171747 | MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…HCG · Special | 07/14/2017SE |
| K171653 | YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back UpDQY · Special | 07/03/2017SE |
| K162563 | YOGA MicrocatheterDQY · Special | 01/05/2017SE |
| K162437 | Codman EDS3 CSF External Drainage SystemJXG · Traditional | 10/28/2016SE |
Questions and answers
When was Codman Bactiseal Catheters cleared by the FDA?
Codman Bactiseal Catheters (K003322) received a 510(k) decision of Substantially Equivalent on October 1, 2001, 342 days after the submission was received.
What is the product code of K003322?
The FDA product code is HCA – Catheter, Ventricular, a Class II (moderate risk) device regulated under 21 CFR 882.4100.