Pace Implant. Lead/Tined/Atrial/J/Model 3290
FDA 510(k) K864153 · Pace Medical
510(k) numberK864153
Submission
- Device name
- Pace Implant. Lead/Tined/Atrial/J/Model 3290
- Applicant
- Pace Medical
Waltham, MA, US - Received
- October 23, 1986
- Decision date
- January 6, 1987
- 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 |
|---|---|---|
| K011980 | Adapter, Pacing Analyzer/Universal Pacing Adapter, Models 4820 and 4825DTE · Traditional | 09/12/2001SE |
| K012392 | Disposable Surgical Extension Cable, Model 4255 and Model 4260DSA · Traditional | 09/04/2001SE |
| K002204 | Pacemaker Extension Cable Models 4265,4265A, 4265V, 5265, 5265A, 5265VDTE · Traditional | 10/18/2000SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | 10/10/2000SE |
| K002496 | Model 4815 AdapterDTN · Traditional | 10/10/2000SE |
| K001180 | Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker…DTE · Traditional | 06/27/2000SE |
| K925143 | Model 4800 Accupace Pacing System AnalyerDTE · Traditional | 09/27/1994SE |
| K931662 | Lead Introducer Set, Various Models and SizesDYB · Traditional | 08/31/1993SE |
| K922899 | Model 4280 Surgical Extension CableDSA · Traditional | 12/23/1992SE |
| K913805 | Miniature Models 4562/4563/4572/4573 PacemakerDTE · Traditional | 11/19/1991SE |
Questions and answers
When was Pace Implant. Lead/Tined/Atrial/J/Model 3290 cleared by the FDA?
Pace Implant. Lead/Tined/Atrial/J/Model 3290 (K864153) received a 510(k) decision of Substantially Equivalent on January 6, 1987, 75 days after the submission was received.
What is the product code of K864153?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.