Implantable Heart Lead Terminal Adapter
FDA 510(k) K790436 · Arco Medical Products Co.
510(k) numberK790436
Submission
- Device name
- Implantable Heart Lead Terminal Adapter
- Applicant
- Arco Medical Products Co.
Mchenry, IL, US - Received
- March 7, 1979
- Decision date
- May 14, 1979
- 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
Other 510(k)s with product code DTD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K802588 | Model 3003 Unipolar Demand Cardiac Gen.DXY · Traditional | 11/19/1980SE |
| K801806 | External Silastic Boot for Cardiac PulseDXY · Traditional | 09/09/1980SE |
| K801241 | Unipolar Programmable Lithium Card. Gen.DXY · Traditional | 06/30/1980SE |
| K800837 | Programmable Bipolar Cardiac GeneratorDXY · Traditional | 06/30/1980SE |
| K800838 | Arcolith 3022&ARCOLITH 3023 Cardiac Gen.DXY · Traditional | 06/04/1980SE |
| K800326 | Arcolith 3021-CARDIAC Pulse GeneratorDXY · Traditional | 03/17/1980SE |
| K792299 | Arcolith 3020-CARDIAC Pulse GeneratorDXY · Traditional | 11/29/1979SE |
| K792216 | Arcolith 2100-CARDIAC Pulse GeneratorDXY · Traditional | 11/29/1979SE |
| K791715 | Arcolith 2000DXY · Traditional | 09/27/1979SE |
| K791147 | Arco Progammable Pacemaker SystemDXY · Traditional | 08/03/1979SE |
Questions and answers
When was Implantable Heart Lead Terminal Adapter cleared by the FDA?
Implantable Heart Lead Terminal Adapter (K790436) received a 510(k) decision of Substantially Equivalent on May 14, 1979, 68 days after the submission was received.
What is the product code of K790436?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.