510(k) K031123
- Device
- CODMAN BACTISEAL BARIUM STRIPED CATHETERS
- Applicant
- Codman & Shurtleff, Inc.
- 510(k) number
- K031123
- Product code
- HCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-05-14
- Date received
- 2003-04-09
- Regulation
- 882.4100
- Classification name
- Catheter, Ventricular
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELIZABETH DOLAN
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3014334038
- 1721983
- 3013886523
- 9612501
- 9617601
- 3004593495
- 3003418325
- 3012507533
- 2032112
- 3015531529
- 3018094310
- 8043933
- 3004721439
- 9610612
- 3017636737
- 2916714
- 2029275
- 2011171
Source Documents#
Other 510(k) Records For Product Code HCA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161731 | Cleveland Multiport Ventricular Catheter Set | Parker Hannifin Corp. | 2017-03-27 |
| K123605 | SMARTFLOW CATHETER | Mri Interventions, Inc. | 2013-08-16 |
| K021481 | BRESAGEN CATHETER, MODEL CS-3000 | Bresagen, Inc. | 2002-08-06 |
| K020728 | MIETHKE SHUNT SYSTEM | Aesculap, Inc. | 2002-04-05 |
| K013005 | ACT 11 MP VENTRICULAR CATHETER | Innerspace, Inc. | 2002-03-08 |
| K003322 | CODMAN BACTISEAL CATHETERS | Codman & Shurtleff, Inc. | 2001-10-01 |
| K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 | Image-Guided Neurologics, Inc. | 1999-10-25 |
| K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 | Medtronic PS Medical | 1998-12-16 |
| K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. | Codman & Shurtleff, Inc. | 1984-03-19 |
Legacy Summary#
summary
FDA Review#
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