Implantable Endocardial Tined Electrode
FDA 510(k) K792387 · Telectronics, Inc.
510(k) numberK792387
Submission
- Device name
- Implantable Endocardial Tined Electrode
- Applicant
- Telectronics, Inc.
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- December 5, 1979
- 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 |
|---|---|---|
| K890895 | Implantable Adaptor 033-380DTD · Traditional | 03/06/1990SE |
| K891231 | Optima MPT and SPT PacemakersDXY · Traditional | 09/12/1989SE |
| K890350 | VS-1 Silicone Implant Leads (New Serial # Tube)DTB · Traditional | 02/02/1989SE |
| K884411 | Optima MPT and SPT PacemakersDXY · Traditional | 01/26/1989SE |
| K884278 | Implantable Electrode Leads 033-400,402 and 436DTB · Traditional | 12/15/1988SE |
| K881837 | Optima MPT Series III Pacemaker, 5281D and 5282DDXY · Traditional | 07/18/1988SE |
| K874664 | Implantable Electrode Lead, Model 030-446DTB · Traditional | 05/31/1988SE |
| K864712 | Model 1740 Personal Pocket ProgrammerKRG · Traditional | 12/17/1987SE |
| K872766 | Implantable Programmable Cardiac Pulse GeneratorsDXY · Traditional | 11/04/1987SE |
| K865098 | Slimline Unipolar Endocardial Pacing Lead, 030-438DTB · Traditional | 08/18/1987SE |
Questions and answers
When was Implantable Endocardial Tined Electrode cleared by the FDA?
Implantable Endocardial Tined Electrode (K792387) received a 510(k) decision of Substantially Equivalent on December 5, 1979, 9 days after the submission was received.
What is the product code of K792387?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.