Permanent Endocard. Unipolar Tined Lead
FDA 510(k) K812905 · Diag Corp.
510(k) numberK812905
Submission
- Device name
- Permanent Endocard. Unipolar Tined Lead
- Applicant
- Diag Corp.
Walker, MI, US - Received
- October 19, 1981
- Decision date
- February 4, 1982
- 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 |
|---|---|---|
| K984062 | Seal-Away Hemostasis Adapter, Model 406229DYB · Traditional | 03/24/1999SE |
| K911883 | Daig Fast Cath(Tm) Transseptal Sheath IntroducerDYB · Traditional | 11/29/1991SE |
| K910645 | Disposable Patient CableDSA · Traditional | 05/07/1991SE |
| K852446 | Endocardial Screw-In Lead with Platinum Porous TipDTB · Traditional | 09/17/1985SE |
| K820003 | Cardiovascular Temp. Pacemaker ElecLDF · Traditional | 03/26/1982SE |
| K820262 | Permanent & Temporary Pacemaker Electr.DTB · Traditional | 03/12/1982SE |
| K812270 | Perm. Endocardial Unipolar Tined AtrialDTB · Traditional | 09/16/1981SE |
| K800349 | Endocard. Pacing Lead Long Length PL200DTB · Traditional | 05/28/1980SE |
Questions and answers
When was Permanent Endocard. Unipolar Tined Lead cleared by the FDA?
Permanent Endocard. Unipolar Tined Lead (K812905) received a 510(k) decision of Substantially Equivalent on February 4, 1982, 108 days after the submission was received.
What is the product code of K812905?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.