FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAMINO VENTRICULAR DRAINAGE SYSTEM
K Number: K932769
·
Decision Mar 30, 1995
Classifications
1
FEI Numbers
68
Registration Numbers
69
Same Product Code
257
Applicant Total
18
Review Days
660
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Basic Information
- Device Name
- CAMINO VENTRICULAR DRAINAGE SYSTEM
- K Number
- K932769
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Camino Laboratories, Inc.
- Date Received
- June 8, 1993
- Decision Date
- March 30, 1995
- Product Code
- JXG
- 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | FDA class 2 | Neurology |
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Other Clearances by Camino Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K930222 | CAMINO VENTRICULAR ACCESS DEVICE | Apr 15, 1993 | Substantially Equivalent |
| K930221 | CAMINO VENTRICULAR TRANSDUCER ACCESSORY | Apr 15, 1993 | Substantially Equivalent |
| K920088 | CAMINO VENTRICULAR NEEDLE | May 1, 1992 | Substantially Equivalent |
| K914735 | VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM | Jan 17, 1992 | Substantially Equivalent |
| K912833 | CAMINO MODEL M420: MONIT INTER W/MEAN PRES DISPLAY | Sep 23, 1991 | Substantially Equivalent |
| K893232 | MODEL V420 DIRECT PRESSURE MONITOR & 427 WAVEFORM | Jul 14, 1989 | Substantially Equivalent |
| K881183 | VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H | May 4, 1988 | Substantially Equivalent |
| K863969 | CAMINO COMPARTMENTAL PRESS MONITOR CATH/110-4D | May 27, 1987 | Substantially Equivalent |
| K861961 | CAMINO CSF DRAINAGE SYSTEM MODEL 040 | Aug 12, 1986 | Substantially Equivalent |
| K862160 | CAMINO HAND DRILL - MODEL 030 | Jul 18, 1986 | Substantially Equivalent |