510(k) K011812
- Device
- SPECTRUM VENTRICULAR CATHETER
- Applicant
- COOK, INC.
- 510(k) number
- K011812
- Product code
- NHC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-08
- Date received
- 2001-06-11
- Regulation
- 882.4100
- Classification name
- Catheter, Ventricular (containing Antibiotic Or Antimicrobial Agents)
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- APRIL LAVENDER
- Address
- 925 S. Curry Pike P.O. Box 489 Bloomington IN US 47402 47402
FDA Registration Numbers#
- 1820334
- 3030447506
- 3030714660
Source Documents#
Other 510(k) Records For Product Code NHC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K160223 | VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter | Cook Incorporated | 2016-04-08 |
| K071640 | VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM | Cook, Inc. | 2007-07-12 |
Legacy Summary#
summary
FDA Review#
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