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

Implantable Pacemaker Pulse-Generator

21 CFR 870.3610 / Cardiovascular
FDA source (opens on fda.gov)

DXY is the FDA product code for Implantable Pacemaker Pulse-Generator, a class III device type, regulated under 21 CFR 870.3610. As of , FDA records hold 461 510(k) clearances under this code, the most recent dated , and 75 recalls.

Classification record

Product code
DXY
Device name
Implantable Pacemaker Pulse-Generator
Regulation
21 CFR 870.3610
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
461
Ingested recalls
75

Clearances, product code DXY

By decision year
461 clearances under product code DXY with a decision year between 1976 and 1999, 1979 the highest year at 52.
Show the numbers
510(k) clearances under FDA product code DXY by decision year
YearClearances
19766
197729
197844
197952
198044
198143
198223
198323
198430
198546
198634
198715
198816
198916
199010
19919
19924
19933
19942
19959
19961
19971
19991

Applicants with the most clearances

Product code DXY
Applicants holding the most 510(k) clearances under product code DXY
ApplicantClearances
Medtronic, Inc.60
Intermedics, Inc.52
Telectronics, Inc.47
Cardiac Pacemakers, Inc.37
Pacesetter Systems28
Cook Pacemaker Corp.24
Biotronik Sales, Inc.22
Ela Medical, Inc.22
Cordis US Corp.21
Arco Medical Products Co.15

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order