DTDClass II

Pacemaker Lead Adaptor

21 CFR 870.3620 / Cardiovascular

DTD is the FDA product code for Pacemaker Lead Adaptor, a class II device type, regulated under 21 CFR 870.3620. As of 2026-09-10, FDA records hold 103 510(k) clearances under this code, the most recent dated 2015-03-19, and no recalls.

Classification record

Product code: DTD
Device name: Pacemaker Lead Adaptor
Regulation: 21 CFR 870.3620
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 103
Ingested recalls: 0

Clearances, product code DTD

By decision year

103 clearances under product code DTD with a decision year between 1977 and 2015, 1985 the highest year at 20.

Show the numbers

510(k) clearances under FDA product code DTD by decision year
Year	Clearances
1977	6
1978	5
1979	6
1980	6
1981	10
1982	5
1983	1
1984	6
1985	20
1986	3
1987	1
1989	2
1990	7
1991	8
1992	2
1994	2
1995	1
1997	3
1998	1
2000	1
2001	2
2003	2
2004	1
2013	1
2015	1

Applicants with the most clearances

Product code DTD

Applicants holding the most 510(k) clearances under product code DTD
Applicant	Clearances
Medtronic, Inc.	20
Pacesetter Systems	20
Intermedics, Inc.	14
Telectronics, Inc.	8
BIOTRONIK AG	6
Cardiac Pacemakers, Inc.	5
Telectronics Pacing Systems, Inc.	5
Oscor Inc.	4
Cordis US Corp.	3
R.E. Brown Co., Inc.	3

Companies listing this code with FDA

Companies whose registered establishments list this code