510(k) K071640
K071640 is an FDA 510(k) premarket notification submitted by Cook, Inc. for the device "VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM". The FDA issued a decision of Substantially Equivalent on July 12, 2007. The device falls under product code NHC (Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)), a Class II device regulated under 21 CFR 882.4100. Cook, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2007
- Date Received
- June 15, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)
- Device Class
- Class II
- Regulation Number
- 882.4100
- Review Panel
- NE
- Submission Type
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.