Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and Passive Fixation
FDA 510(k) K964604 · Biotronik, Inc.
510(k) numberK964604
Submission
- Device name
- Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and Passive Fixation
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- November 18, 1996
- Decision date
- March 10, 1997
- Decision
- Substantially Equivalent - Subject to Tracking & PMS (PT)
- 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 |
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| K240787 | Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool…DQY · Traditional | 09/12/2024SE |
| K241711 | Oscar Peripheral Multifunctional Catheter systemLIT · Special | 07/11/2024SE |
| K230375 | Biomonitor IVMXD · Traditional | 05/19/2023SE |
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| K221856 | BIOMONITOR IIIm, BIOMONITOR IIIMXD · Special | 07/27/2022SE |
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Questions and answers
When was Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and Passive Fixation cleared by the FDA?
Bipolar Implantable Endocardial Pacing Leads, with Silicone Rubber Insulation and Passive Fixation (K964604) received a 510(k) decision of Substantially Equivalent - Subject to Tracking & PMS on March 10, 1997, 112 days after the submission was received.
What is the product code of K964604?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.