Biotronik DNP Unipolar
FDA 510(k) K841450 · Biotronik Sales, Inc.
510(k) numberK841450
Submission
- Device name
- Biotronik DNP Unipolar
- Applicant
- Biotronik Sales, Inc.
Mchenry, IL, US - Received
- April 9, 1984
- Decision date
- February 7, 1985
- 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 |
|---|---|---|
| K875199 | NP Bipolar Endocardial Lead W/VS-1 ConnectorDTB · Traditional | 02/18/1988SE |
| K853194 | ERA-20DTE · Traditional | 03/11/1987SE |
| K860036 | EDP-20 PacemakerDXY · Traditional | 01/12/1987SE |
| K863879 | Neos-M VS-1 Pulse GeneratorDXY · Traditional | 12/10/1986SE |
| K863878 | Trios-M VS-1 Pulse GeneratorDXY · Traditional | 12/10/1986SE |
| K863480 | Biotronik Permanent Pacemaker ElectrodeDTB · Traditional | 09/23/1986SE |
| K860921 | Neos VS-1, Pulse GeneratorDXY · Traditional | 08/08/1986SE |
| K860922 | Mikros, Mikros VS-1, Pulse GeneratorDXY · Traditional | 08/04/1986SE |
| K853567 | DJP UnipolarDTB · Traditional | 05/07/1986SE |
| K853566 | DJ UnipolarDTB · Traditional | 05/07/1986SE |
Questions and answers
When was Biotronik DNP Unipolar cleared by the FDA?
Biotronik DNP Unipolar (K841450) received a 510(k) decision of Substantially Equivalent on February 7, 1985, 304 days after the submission was received.
What is the product code of K841450?
The FDA product code is DTD – Pacemaker Lead Adaptor, a Class II (moderate risk) device regulated under 21 CFR 870.3620.