SPECTRUM VENTRICULAR CATHETER— 510(k) K011812

Clearance details

Applicant

Cook, Inc.

Product code

Code NHC

Device class

Class 2

Regulation

21 CFR 882.4100

Advisory panel

Neurology

Date received

2001-06-11

Decision date

2001-11-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bloomington, IN, US

• K160223 — VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter2016-04-08
• K071640 — VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM2007-07-12

• K133130 — BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER2015-01-09
• K140593 — ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE2014-12-15
• K132592 — FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET2014-10-09
• K133597 — CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY2014-04-18
• K131772 — CANTATA(R) 2.9 MICROCATHETER2014-02-20

• Z-2791-2018 — VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of relieving elevated intracranial pressure or fluid volume.Class II·Terminated·Cook Inc.·20180531

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011812.