510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KFJClass III

Materials, Repair Or Replacement, Pacemaker

21 CFR 870.3710 / Cardiovascular
FDA source (opens on fda.gov)

KFJ is the FDA product code for Materials, Repair Or Replacement, Pacemaker, a class III device type, regulated under 21 CFR 870.3710. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KFJ
Device name
Materials, Repair Or Replacement, Pacemaker
Regulation
21 CFR 870.3710
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code KFJ

By decision year
3 clearances under product code KFJ with a decision year between 1982 and 1991, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KFJ by decision year
YearClearances
19821
19851
19911

Applicants with the most clearances

Product code KFJ
Applicants holding the most 510(k) clearances under product code KFJ
ApplicantClearances
Intermedics, Inc.1
Medtronic, Inc.1
Telectronics Pacing Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code KFJ.