Catheter, Ventricular
Regulation 882.4100
0510(k)s in 12 months (10 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in HCA
| Company | 510(k)s | Recalls |
|---|---|---|
| Codman & Shurtleff, Inc. | 3 | 1 |
| Vygon Neuro | 0 | 3 |
| Aesculap, Inc. | 1 | 0 |
| Bresagen, Inc. | 1 | 0 |
| Image-Guided Neurologics, Inc. | 1 | 0 |
| Innerspace, Inc. | 1 | 0 |
| Integra Life Sciences Corp. | 0 | 1 |
| Integra LifeSciences Corp. | 0 | 1 |
| Medtronic PS Medical | 1 | 0 |
| Mri Interventions, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2017 | K161731 | Cleveland Multiport Ventricular Catheter Set Parker Hannifin Corp. | HCA |
| Aug 16, 2013 | K123605 | SMARTFLOW CATHETER Mri Interventions, Inc. | HCA |
| May 14, 2003 | K031123 | CODMAN BACTISEAL BARIUM STRIPED CATHETERS Codman & Shurtleff, Inc. | HCA |
| Aug 6, 2002 | K021481 | BRESAGEN CATHETER, MODEL CS-3000 Bresagen, Inc. | HCA |
| Apr 5, 2002 | K020728 | MIETHKE SHUNT SYSTEM Aesculap, Inc. | HCA |
| Mar 8, 2002 | K013005 | ACT 11 MP VENTRICULAR CATHETER Innerspace, Inc. | HCA |
| Oct 1, 2001 | K003322 | CODMAN BACTISEAL CATHETERS Codman & Shurtleff, Inc. | HCA |
| Oct 25, 1999 | K992796 | ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 Image-Guided Neurologics, Inc. | HCA |
| Dec 16, 1998 | K983331 | MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 Medtronic PS Medical | HCA |
| Mar 19, 1984 | K834477 | DISPOS. SCOTT CANNULAS 16-1054 ETC. Codman & Shurtleff, Inc. | HCA |
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