Apc Implantabel Pacing Lead, Model 3264
FDA 510(k) K810399 · American Pacemaker Corp.
510(k) numberK810399
Submission
- Device name
- Apc Implantabel Pacing Lead, Model 3264
- Applicant
- American Pacemaker Corp.
Mchenry, IL, US - Received
- February 18, 1981
- Decision date
- May 15, 1981
- 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 |
|---|---|---|
| K821791 | External Pulse Generator - EV4542DTE · Traditional | 07/06/1982SE |
| K812830 | Apc Implantable Pacing LeadDTB · Traditional | 01/18/1982SE |
| K812807 | Apc Implantable Pacing LeadsDTB · Traditional | 01/18/1982SE |
| K810398 | Apc Implantable Pacing Lead, Model 3266DTB · Traditional | 05/15/1981SE |
| K810397 | Apc Implantable Pacing Lead-Flange #3260DTB · Traditional | 05/15/1981SE |
| K810396 | Apc Implantable Pacing Lead, Tined #3262DTB · Traditional | 05/15/1981SE |
| K810121 | Unifocal 3DXY · Traditional | 02/23/1981SE |
| K800746 | Unifocal VP, Models 7501 and 7502DXY · Traditional | 12/16/1980SE |
| K800379 | Bifocal 2 8200 Series (A,B C,D)DXY · Traditional | 09/26/1980SE |
| K792232 | Unifocal 3-2 Models Unipolar & BipolarDXY · Traditional | 11/27/1979SE |
Questions and answers
When was Apc Implantabel Pacing Lead, Model 3264 cleared by the FDA?
Apc Implantabel Pacing Lead, Model 3264 (K810399) received a 510(k) decision of Substantially Equivalent on May 15, 1981, 86 days after the submission was received.
What is the product code of K810399?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.