Coaxial Bipolar Pacing Electrode
FDA 510(k) K822239 · Burditt & Calkins-Siemens-Elema
510(k) numberK822239
Submission
- Device name
- Coaxial Bipolar Pacing Electrode
- Applicant
- Burditt & Calkins-Siemens-Elema
Mchenry, IL, US - Received
- July 28, 1982
- Decision date
- October 4, 1982
- 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 |
|---|---|---|
| K833519 | Pulse Generator Model 688DXY · Traditional | 01/30/1984SE |
| K833155 | Rayden Medical Mini Pulse Volume RecordDSB · Traditional | 01/26/1984SE |
| K830344 | Siemens-Elma Pulse Generator #718DXY · Traditional | 05/27/1983SE |
| K823435 | Mon-A-Therm Myocardial Temp. SensorKRB · Traditional | 12/30/1982SE |
| K823591 | Ameda Hand Breast PumpHGY · Traditional | 12/28/1982SE |
| K821712 | Informed Remote Field Unit Model IFM1000BTY · Traditional | 07/26/1982SE |
| K803111 | ErectaidFAE · Traditional | 01/23/1981SE |
| K802607 | Terperatur Sensing DeviceFLL · Traditional | 11/19/1980SE |
| K760787 | Liberator/StrollerBYJ · Traditional | 10/22/1976SE |
Questions and answers
When was Coaxial Bipolar Pacing Electrode cleared by the FDA?
Coaxial Bipolar Pacing Electrode (K822239) received a 510(k) decision of Substantially Equivalent on October 4, 1982, 68 days after the submission was received.
What is the product code of K822239?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.