Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads
FDA 510(k) K993448 · Ela Medical, Inc.
510(k) numberK993448
Submission
- Device name
- Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads
- Applicant
- Ela Medical, Inc.
Plymouth, MN, US - Received
- October 12, 1999
- Decision date
- April 10, 2000
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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 |
|---|---|---|
| K042002 | Synescope, Easyscope, Synecom, HolterreaderDQK · Traditional | 10/20/2004SE |
| K032466 | SpiderviewMWJ · Special | 08/22/2003SE |
| K002817 | SynetecDQK · Traditional | 05/02/2001SE |
| K000029 | Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…DTB · Traditional | 04/04/2000SE |
| K990727 | Syneflash & SyneviewDQK · Traditional | 11/26/1999SE |
| K972574 | Stela Model UJ45 Pacing LeadsDTB · Traditional | 01/08/1998ST |
| K970072 | Opus S Model 4121 and 4124 PacemakersDXY · Traditional | 08/29/1997ST |
| K963738 | Stela Model BJ44 and BJ45 Pacing LeadsDTB · Traditional | 05/23/1997PT |
| K952364 | Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)DXY · Traditional | 09/01/1995ST |
| K952363 | Opus Pacemakers (Models 4021, 4033, and 4034)ELA · Traditional | 08/15/1995SE |
Questions and answers
When was Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads cleared by the FDA?
Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads (K993448) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on April 10, 2000, 181 days after the submission was received.
What is the product code of K993448?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.