Permanent Pacing Lead W/Polaris Coated Tips, Various Models
FDA 510(k) K013339 · Oscor, Inc.
510(k) numberK013339
Submission
- Device name
- Permanent Pacing Lead W/Polaris Coated Tips, Various Models
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- October 9, 2001
- Decision date
- November 8, 2001
- 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 |
| 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 |
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Questions and answers
When was Permanent Pacing Lead W/Polaris Coated Tips, Various Models cleared by the FDA?
Permanent Pacing Lead W/Polaris Coated Tips, Various Models (K013339) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on November 8, 2001, 30 days after the submission was received.
What is the product code of K013339?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.