FDA product code DTD: Pacemaker Lead Adaptor
DTD is the FDA product code for pacemaker lead adaptor. It is a Class II device, regulated under 21 CFR 870.3620 and reviewed by the Cardiovascular panel. FDA has cleared 103 510(k) submissions under DTD, from 23 different applicants. The average 510(k) review took 86 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Pacemaker Lead Adaptor |
| Device class | Class II |
| Regulation | 21 CFR 870.3620 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every DTD clearance
Top DTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pacesetter Systems | 20 | 1990-06-25 |
| Medtronic Vascular | 19 | 2000-02-23 |
| Intermedics, Inc. | 14 | 1989-09-05 |
| Telectronics, Inc. | 8 | 1990-03-06 |
| Telectronics Pacing Systems, Inc. | 5 | 1994-05-12 |
18 more applicants have DTD clearances. See the full list in Caduvo.
Most recent DTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143463 | Oscor, Inc. | IS4/DF4 Port Plug | 2015-03-19 | 105 |
| K132008 | Medtronic, Inc. | 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP | 2013-07-30 | 29 |
| K041574 | Guidant Corporation | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 | 2004-07-12 | 28 |
| K031164 | Oscor, Inc. | PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV | 2003-06-19 | 66 |
| K024156 | Oscor, Inc. | PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR | 2003-01-14 | 28 |
Recalls for DTD devices
openFDA lists no recalls for product code DTD.
Frequently asked questions
What is FDA product code DTD?
DTD is the FDA product code for pacemaker lead adaptor. It is a Class II device, regulated under 21 CFR 870.3620 and reviewed by the Cardiovascular panel.
What device class is DTD?
Class II, regulation 21 CFR 870.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code DTD?
Across 103 cleared submissions the average was 86 days from receipt to decision (median 66).
Which companies have the most DTD clearances?
Pacesetter Systems (20); Medtronic Vascular (19); Intermedics, Inc. (14); Telectronics, Inc. (8); Telectronics Pacing Systems, Inc. (5).
Next steps
- Run an FDA pathway report with predicate devices for product code DTD
- Run a recall and safety report across every DTD manufacturer
- Watch product code DTD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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