Implantable Electrode Unipolar Adapt
FDA 510(k) K840026 · Telectronics, Inc.
510(k) numberK840026
Submission
- Device name
- Implantable Electrode Unipolar Adapt
- Applicant
- Telectronics, Inc.
Mchenry, IL, US - Received
- January 5, 1984
- Decision date
- May 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTD – Pacemaker Lead Adaptor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3620
- Specialty
- Cardiovascular
- Implant
- Yes
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|---|---|---|---|
| K143463 | IS4/DF4 Port PlugDTD · Traditional | Oscor, Inc. | 03/19/2015SE |
| K132008 | 6981M Lead Extender Kit, 6984M Lead Extender Kit, 6986M Lead Extender Kit, 5866-24M Lead…DTD · Special | Medtronic, Inc. | 07/30/2013SE |
| K041574 | Cpi Lead Adapters, Models 6017, 6018 and 6020DTD · Special | Guidant Corporation | 07/12/2004SE |
| K031164 | Pacing Lead Adaptors, Bipolar, Models Ilink-Bis, Ilink-BlvDTD · Special | Oscor, Inc. | 06/19/2003ST |
| K024156 | Pacing Lead Extensions, Bipolar, Pacing Lead Adaptors, Unipolar/Bipolar,Pacing Lead…DTD · Special | Oscor, Inc. | 01/14/2003SE |
| K010787 | Pacing Lead Bipolar Adapters and ExtensionsDTD · Traditional | Oscor, Inc. | 05/22/2001SE |
| K003454 | A1-CS-SB Y-Adapter, Model 124 871DTD · Special | Biotronik, Inc. | 01/18/2001ST |
| K000210 | Modification to Model 5866-37M Lead Adaptor KitDTD · Special | Medtronic Vascular | 02/23/2000ST |
| K982220 | Model 2872 Bipolar Lead Adaptor KitDTD · Traditional | Medtronic Vascular | 10/15/1998ST |
| K971930 | Bk-N Sealing CapDTD · Traditional | Biotronik, Inc. | 08/14/1997PT |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890895 | Implantable Adaptor 033-380DTD · Traditional | 03/06/1990SE |
| K891231 | Optima MPT and SPT PacemakersDXY · Traditional | 09/12/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | 02/02/1989SE |
| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | 12/15/1988SE |
| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | 12/17/1987SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | 08/18/1987SE |
Questions and answers
When was Implantable Electrode Unipolar Adapt cleared by the FDA?
Implantable Electrode Unipolar Adapt (K840026) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 139 days after the submission was received.
What is the product code of K840026?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.