VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
FDA 510(k) clearance K071640 · decided 2007-07-12
Clearance details
- K-number
- K071640
- Device name
- VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM
- Applicant
- Cook, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-15
- Decision date
- 2007-07-12
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- NHC
- Device class
- 2
- Regulation number
- 882.4100
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
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| VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter (K160223) | Cook Incorporated | 2016-04-08 |
| SPECTRUM VENTRICULAR CATHETER (K011812) | Cook, Inc. | 2001-11-08 |
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| Record | Firm | Date |
|---|---|---|
| VentriClear II Ventricular Drainage Catheter Set. Allows external access and drainage of c recall (Z-0416-2016) | Cook Inc. | 2015-12-14 |
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