DNR Unipolar
FDA 510(k) K853568 · Biotronik Sales, Inc.
510(k) numberK853568
Submission
- Device name
- DNR Unipolar
- Applicant
- Biotronik Sales, Inc.
Lake Oswego, OR, US - Received
- August 26, 1985
- Decision date
- January 15, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTB – Permanent Pacemaker Electrode
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 870.3680
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DTB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061212 | Biotronik Endocardial Pacing LeadsDTB · Special | Biotronik, Inc. | 07/10/2006SE |
| K041809 | Permanent Pacing Lead, Model PY2DTB · Special | Oscor, Inc. | 08/06/2004SE |
| K040569 | Permanent Pacing Lead, Model Refino, Model: Refino-R, Ru, RjuDTB · Special | Oscor, Inc. | 04/07/2004SE |
| K031274 | Model 5071 Myocardial Pacing LeadDTB · Special | Medtronic Vascular | 05/22/2003ST |
| K031210 | Model 4951M Myocardial Unipolar LeadDTB · Special | Metronic, Inc. | 05/16/2003SE |
| K023205 | Elox P 45-BP; Elox P 53-BP; Elox P 60-BPDTB · Traditional | Biotronik, Inc. | 04/24/2003ST |
| K024053 | Permanent Pacing Leads, Models Physique PB and PJBDTB · Special | Oscor, Inc. | 01/31/2003SE |
| K023803 | Modification to Biotronik's Sterilization ProcessDTB · Special | Biotronik, Inc. | 12/11/2002SE |
| K023099 | Arox 45-JBP; Arox 53-JBP; Merox 45-JBP; Merox 53-JBPDTB · Special | Biotronik, Inc. | 10/18/2002SE |
| K021217 | Arox 53-BP; Arox 60-BP; Arox 45-JBP; Arox 53-JBPDTB · Special | Biotronik, Inc. | 05/01/2002SE |
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 DNR Unipolar cleared by the FDA?
DNR Unipolar (K853568) received a 510(k) decision of Substantially Equivalent on January 15, 1986, 142 days after the submission was received.
What is the product code of K853568?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.