Product code LKG— Neurology

FDA has cleared 8 devices under product code LKG between 1983 and 1995, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19951 clearance
• 19884 clearances
• 19842 clearances
• 19831 clearance

• Pudenz-Schulte Medical Research Corp.3 clearances
• Pharmacia Deltec, Inc.2 clearances
• Holter-Hausner Intl.1 clearance
• Cordis Corp.1 clearance
• American Heyer Schulte1 clearance

• K950315 — CORDIS CSF RESERVOIRCordis Corp.·1995-05-09
• K881493 — PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.Pharmacia Deltec, Inc.·1988-05-20
• K881690 — PORT-A-CATH PORTAL INTRODUCER FORCEPSPharmacia Deltec, Inc.·1988-05-20
• K874468 — P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.·1988-02-11
• K874498 — CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.·1988-02-11
• K833822 — P-S MEDICAL CSF ACCESS DEV 15MM/25MMPudenz-Schulte Medical Research Corp.·1984-05-25
• K833672 — HH SUBCUTANEOUS ACCESS PORTHolter-Hausner Intl.·1984-03-06
• K823790 — VENTRICULAR ACCESS SYSTEMAmerican Heyer Schulte·1983-04-28