FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
K Number: K983331
·
Decision Dec 16, 1998
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
9
Applicant Total
14
Review Days
85
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Basic Information
- Device Name
- MEDTRONIC PS MEDICAL INNERVISION VENTRICULAR CATHETER, 15CM MODEL 99102
- K Number
- K983331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4100
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic PS Medical
- Date Received
- September 22, 1998
- Decision Date
- December 16, 1998
- 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 Medtronic PS Medical
| K Number | Device Name | ||
|---|---|---|---|
| K012052 | MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855 | Feb 11, 2002 | Substantially Equivalent |
| K010361 | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 | May 7, 2001 | Substantially Equivalent |
| K010487 | BIPOLAR PENCIL, MODEL 3901-002, 3900-002 | May 3, 2001 | Substantially Equivalent |
| K010341 | MEDTRONIC PS MEDICAL MURPHYSCOPE, MODELS 2125-032, 2125033,2125-042, 2125-043, 2125-157, 2125-158,2125-161 2125-162,, | Apr 20, 2001 | Substantially Equivalent |
| K003914 | MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES | Feb 22, 2001 | Substantially Equivalent |
| K002572 | MEDTRONIC PS MEDICAL CHANNELSCOPE ENDOSCOPE, MODELS 2232-001, 2232-002, 2232-003, 2232-004, 2233-002, 2233-005 | Nov 16, 2000 | Substantially Equivalent |
| K991502 | MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022 | Sep 12, 2000 | Substantially Equivalent |
| K990333 | MEDTRONIC PS MEDICAL INTRODUCER SHEATH 12F,14F,15F, MODELS 3805-012, 3805-014, 3805-015 | Apr 28, 1999 | Substantially Equivalent |
| K984053 | BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM | Feb 4, 1999 | Substantially Equivalent |
| K983799 | MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL | Jan 26, 1999 | Substantially Equivalent |