Product code HCA
- Device name
- Catheter, Ventricular
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.4100
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS | Codman & Shurtleff, Inc. | 2003-05-14 |
| 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 |
Related GUDID Devices#
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|---|---|---|---|
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| 10381780537069 | CODMAN® BACTISEAL® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-11-20 |
| 10381780537045 | CODMAN® BACTISEAL® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-11-20 |
| 10381780537038 | CODMAN® BACTISEAL® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-11-20 |
| 10381780537021 | CODMAN® BACTISEAL® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-11-20 |
| 10381780537014 | CODMAN® BACTISEAL® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-11-20 |
| 10381780535867 | CODMAN® CERTAS® Plus | Integra LifeSciences Switzerland Sàrl | 2024-11-20 |
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| 10381780535430 | CODMAN® CERTAS® Plus | Integra LifeSciences Switzerland Sàrl | 2024-11-20 |
| 10381780535805 | CODMAN® CERTAS® Plus | Integra LifeSciences Switzerland Sàrl | 2024-11-20 |
| 10381780535829 | CODMAN® CERTAS® Plus | Integra LifeSciences Switzerland Sàrl | 2024-11-20 |
| 10381780537052 | CODMAN® BACTISEAL® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2024-11-20 |
| 10381780535843 | CODMAN® CERTAS® Plus | Integra LifeSciences Switzerland Sàrl | 2024-11-20 |
| 00763000333614 | Exacta™ | MEDTRONIC PS MEDICAL, INC. | 2020-06-08 |
| 10381780521136 | CODMAN CERTAS® Plus | Integra LifeSciences Switzerland Sàrl | 2020-06-03 |
| 10381780511540 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 10381780511557 | CODMAN® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-04-01 |
| 04041906120405 | AESCULAP | Christoph Miethke GmbH & Co. KG | 2015-09-24 |
| 00613994908483 | Innervision | MEDTRONIC PS MEDICAL, INC. | 2015-07-21 |
| 00613994908476 | Innervision, BioGlide® | MEDTRONIC PS MEDICAL, INC. | 2015-07-21 |
| 00613994908254 | Innervision | MEDTRONIC PS MEDICAL, INC. | 2015-06-11 |