Oscor Permanent Retractable Screw-In Pacing Lead Model PR
FDA 510(k) K964107 · Oscor Medical Corp.
510(k) numberK964107
Submission
- Device name
- Oscor Permanent Retractable Screw-In Pacing Lead Model PR
- Applicant
- Oscor Medical Corp.
Palm Harbor, FL, US - Received
- October 15, 1996
- Decision date
- April 1, 1997
- Decision
- Substantially Equivalent - Subject to Tracking & PMS (PT)
- 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 |
|---|---|---|
| K925168 | Miscellaneous Pacing LeadDTD · Traditional | 05/03/1994SE |
| K923621 | External Demand PacemakerDTE · Traditional | 05/19/1993SE |
| K912867 | Oscor Medical Corp Permanent Pacing LeadDTB · Traditional | 02/04/1992SE |
| K915008 | Permanent Pacing Pad, ModificationDTB · Traditional | 01/27/1992SE |
| K915007 | Permanent Pacing Leads, ModificationDTB · Traditional | 01/27/1992SE |
| K913393 | Implant Pacing Lead, Retractable, ModificationDTB · Traditional | 09/23/1991SE |
| K913205 | Oscor Medical Fix Screw Pac Lead/Peel Cath, ModifDTB · Traditional | 09/23/1991SE |
| K913204 | Model Ky Pacemaker Lead-Various, ModificationDTB · Traditional | 09/23/1991SE |
| K913203 | Implant Pacing Lead Tined #3390, ModificationDTB · Traditional | 09/23/1991SE |
| K913202 | Implant Pacing Lead, Tined #3262, ModificationDTB · Traditional | 09/23/1991SE |
Questions and answers
When was Oscor Permanent Retractable Screw-In Pacing Lead Model PR cleared by the FDA?
Oscor Permanent Retractable Screw-In Pacing Lead Model PR (K964107) received a 510(k) decision of Substantially Equivalent - Subject to Tracking & PMS on April 1, 1997, 168 days after the submission was received.
What is the product code of K964107?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.