ACT 11 MP VENTRICULAR CATHETER
FDA 510(k) clearance K013005 · decided 2002-03-08
Clearance details
- K-number
- K013005
- Device name
- ACT 11 MP VENTRICULAR CATHETER
- Applicant
- Innerspace, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-06
- Decision date
- 2002-03-08
- Days to decision
- 183 days
- Clearance type
- Traditional
- Product code
- HCA
- Device class
- 2
- Regulation number
- 882.4100
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Cleveland Multiport Ventricular Catheter Set (K161731) | Parker Hannifin Corp. | 2017-03-27 |
| SMARTFLOW CATHETER (K123605) | Mri Interventions, Inc. | 2013-08-16 |
| CODMAN BACTISEAL BARIUM STRIPED CATHETERS (K031123) | Codman & Shurtleff, Inc. | 2003-05-14 |
| BRESAGEN CATHETER, MODEL CS-3000 (K021481) | Bresagen, Inc. | 2002-08-06 |
| MIETHKE SHUNT SYSTEM (K020728) | Aesculap, Inc. | 2002-04-05 |
| CODMAN BACTISEAL CATHETERS (K003322) | Codman & Shurtleff, Inc. | 2001-10-01 |
| ASPIRATION/IRRIGATION CATHETER, MODEL AC-1000 (K992796) | Image-Guided Neurologics, Inc. | 1999-10-25 |
| MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102 (K983331) | Medtronic PS Medical | 1998-12-16 |
| DISPOS. SCOTT CANNULAS 16-1054 ETC. (K834477) | Codman & Shurtleff, Inc. | 1984-03-19 |
Recalls involving this device
No recalls on record reference this clearance.