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

Pulse-Generator, Pacemaker, External

21 CFR 870.3600 / Cardiovascular
FDA source (opens on fda.gov)

DTE is the FDA product code for Pulse-Generator, Pacemaker, External, a class II device type, regulated under 21 CFR 870.3600. As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
DTE
Device name
Pulse-Generator, Pacemaker, External
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
65
Ingested recalls
5

Clearances, product code DTE

By decision year
65 clearances under product code DTE with a decision year between 1978 and 2025, 1980 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code DTE by decision year
YearClearances
19782
19791
19806
19813
19823
19832
19853
19862
19874
19881
19891
19903
19913
19922
19931
19943
19961
19974
20002
20011
20022
20032
20041
20132
20151
20162
20182
20192
20201
20241
20251

Applicants with the most clearances

Product code DTE
Applicants holding the most 510(k) clearances under product code DTE
ApplicantClearances
Medtronic, Inc.13
Seamed Corp.13
Pace Medical9
Cynergy4
Osypka Medical GmbH4
Telectronics, Inc.3
BIOTRONIK AG2
Intermedics, Inc.2
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.2
ZOLL Medical Corporation2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order