Model 5071 Myocardial Pacing Lead
FDA 510(k) K031274 · Medtronic Vascular
510(k) numberK031274
Submission
- Device name
- Model 5071 Myocardial Pacing Lead
- Applicant
- Medtronic Vascular
Minneapolis, MN, US - Received
- April 22, 2003
- Decision date
- May 22, 2003
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Special 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 |
| 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 |
| K010281 | Merox Bipolar High Impedance Lead Models: Mex 53/13-BP; 60/15-BP; 45-JBP; 53-JBPDTB · Traditional | Biotronik, Inc. | 04/09/2002SE |
More from Biotronik, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232570 | Steerant Super Stiff GuidewireDQX · Traditional | 10/24/2023SE |
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterDQY · Special | 08/22/2023SE |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F…DQY · Special | 06/30/2023SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | 04/13/2022SE |
| K192296 | Medtronic 6F Taiga Guiding CatheterDQY · Special | 09/20/2019SE |
| K182957 | Heli-FX EndoAnchor SystemOTD · Special | 11/21/2018SE |
| K173515 | Admiral XtremeLIT · Traditional | 04/12/2018SE |
| K171866 | Sentrant Introducer Sheath with Hydrophilic CoatingDYB · Special | 12/20/2017SE |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | 06/16/2017SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | 06/13/2017SE |
Questions and answers
When was Model 5071 Myocardial Pacing Lead cleared by the FDA?
Model 5071 Myocardial Pacing Lead (K031274) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on May 22, 2003, 30 days after the submission was received.
What is the product code of K031274?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.