Product code KFJ— Cardiovascular

IMPLANT AID SPLICING CRIMP & SLEEVE

Classification name: Materials, Repair Or Replacement, Pacemaker
Device class: Class 3
Regulation: 21 CFR 870.3710
Advisory panel: Cardiovascular
Total cleared: 3
First cleared: 1982-01-12
Most recent: 1991-12-31

Market context for product code KFJ

FDA has cleared 3 devices under product code KFJ between 1982 and 1991, filed by 3 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.

Clearances per year

19911 clearance
19851 clearance
19821 clearance

Top applicants under product code KFJ

Telectronics Pacing Systems, Inc.1 clearance
Medtronic Vascular1 clearance
Intermedics, Inc.1 clearance

Recent clearances under product code KFJ

K913919 — UNIVERSAL TERMINAL CAP, 3.2MMTelectronics Pacing Systems, Inc.·1991-12-31
K852236 — MEDTRONIC MODEL 5867-1AMedtronic Vascular·1985-07-11
K813518 — IMPLANT AID SPLICING CRIMP & SLEEVEIntermedics, Inc.·1982-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.