Pacing Lead Model Bus 860, Bus 890
FDA 510(k) K781624 · R.E. Brown Co., Inc.
510(k) numberK781624
Submission
- Device name
- Pacing Lead Model Bus 860, Bus 890
- Applicant
- R.E. Brown Co., Inc.
Mchenry, IL, US - Received
- September 20, 1978
- Decision date
- December 21, 1978
- 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 |
|---|---|---|
| K781627 | Pacing Lead Adapter Model Adb 21DTD · Traditional | 12/08/1978SE |
| K781626 | Pacing Lead Adapter, Acv 14, Acv 23DTD · Traditional | 12/08/1978SE |
| K781625 | Pacing Lead Model MVM 860, MVM 890DTB · Traditional | 12/08/1978SE |
| K781623 | Pacing Models Mum 860, Mum 890DTB · Traditional | 12/08/1978SE |
| K781622 | Pacing Lead Adapter Model Acs 16DTD · Traditional | 12/08/1978SE |
| K781621 | Pacing Lead Models, Mam 1260 Mam 1290DTB · Traditional | 12/08/1978SE |
| K781620 | Pacing Lead Models, MDM 1060, MDM 1090DTB · Traditional | 12/08/1978SE |
| K781619 | Pacing Lead Models SA, 350, Sam 500DTB · Traditional | 12/08/1978SE |
| K780781 | Stilith Cardiac Pacemakers-M. 60 & 120DXY · Traditional | 07/27/1978SE |
Questions and answers
When was Pacing Lead Model Bus 860, Bus 890 cleared by the FDA?
Pacing Lead Model Bus 860, Bus 890 (K781624) received a 510(k) decision of Substantially Equivalent on December 21, 1978, 92 days after the submission was received.
What is the product code of K781624?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.