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

Programmer, Pacemaker

21 CFR 870.3700 / Cardiovascular
FDA source (opens on fda.gov)

KRG is the FDA product code for Programmer, Pacemaker, a class III device type, regulated under 21 CFR 870.3700. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
KRG
Device name
Programmer, Pacemaker
Regulation
21 CFR 870.3700
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
11

Clearances, product code KRG

By decision year
25 clearances under product code KRG with a decision year between 1977 and 1995, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KRG by decision year
YearClearances
19771
19781
19793
19801
19814
19821
19841
19853
19864
19872
19882
19891
19951

Applicants with the most clearances

Product code KRG
Applicants holding the most 510(k) clearances under product code KRG
ApplicantClearances
Cardiac Pacemakers, Inc.7
Intermedics, Inc.4
Cordis US Corp.3
Vitatron Medical BV3
Telectronics, Inc.2
Biotronik Sales, Inc.1
Medtronic, Inc.1
Nova Medical Specialties1
Pacesetter Systems1
Teletronics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order