FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACT 11 MP VENTRICULAR CATHETER
K Number: K013005
·
Decision Mar 8, 2002
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
8
Review Days
183
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Basic Information
- Device Name
- ACT 11 MP VENTRICULAR CATHETER
- K Number
- K013005
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innerspace, Inc.
- Date Received
- September 6, 2001
- Decision Date
- March 8, 2002
- Product Code
- HCA
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HCA | Catheter, Ventricular | FDA class 2 | Neurology |
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Other Clearances by Innerspace, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K113088 | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | May 2, 2012 | Substantially Equivalent |
| K083378 | SYNERGY | Sep 29, 2009 | Substantially Equivalent |
| K072379 | MPS OXIPORT AND MPS OXIPORT PLUS | Apr 29, 2008 | Substantially Equivalent |
| K041838 | MPS (OR MPS-T) | Mar 1, 2005 | Substantially Equivalent |
| K013705 | ACT III VENTRICULAR CATHETER | Sep 9, 2002 | Substantially Equivalent |
| K010422 | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | Jun 28, 2001 | Substantially Equivalent |
| K003905 | ACTI-ICP MONITORING SYSTEM | Jun 15, 2001 | Substantially Equivalent |