Sentra
FDA 510(k) K843060 · Cardiac Pacemakers, Inc.
510(k) numberK843060
Submission
- Device name
- Sentra
- Applicant
- Cardiac Pacemakers, Inc.
Walker, MI, US - Received
- August 3, 1984
- Decision date
- September 20, 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 |
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| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | 01/10/1994SE |
| K920601 | Astra T2, Astra T4, Astra T6DXY · Traditional | 10/28/1992SE |
| K912379 | PDT Carryall Transmitter, Various ModelsDXH · Traditional | 06/17/1991SE |
| K905674 | Lead StyletDRB · Traditional | 01/30/1991SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | 02/23/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | 09/13/1989SE |
| K890785 | Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional | 03/10/1989SE |
| K875147 | Torque Hex WrenchDTF · Traditional | 01/27/1988SE |
Questions and answers
When was Sentra cleared by the FDA?
Sentra (K843060) received a 510(k) decision of Substantially Equivalent on September 20, 1984, 48 days after the submission was received.
What is the product code of K843060?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.