Model P In-Line Bipolar Endocardial Tined Lead
FDA 510(k) K915188 · Cook Pacemaker Corp.
510(k) numberK915188
Submission
- Device name
- Model P In-Line Bipolar Endocardial Tined Lead
- Applicant
- Cook Pacemaker Corp.
Leechburg, PA, US - Received
- November 18, 1991
- Decision date
- September 11, 1992
- Decision
- Unknown (SESP)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 510(k) | Device | Decision |
|---|---|---|
| K970690 | Locking Stylet 2DQX · Traditional | 05/20/1997SE |
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| K953417 | Miniflex Model 340, 341, and 342 Pulse GeneratorsDXY · Traditional | 09/29/1995ST |
| K905403 | Model 340 Series Unipolar & Model 5000B ProgrammerDXY · Traditional | 10/16/1991SE |
| K863582 | Model 725TH Handheld Transceiver (Programmer)DXY · Traditional | 10/08/1986SE |
| K861559 | Series (T) Programmable Cardiac Pulse GeneratorsDXY · Traditional | 05/09/1986SE |
| K860466 | Model 329D, Seriers R Biopolar Cardiac Pul. Gen.DXY · Traditional | 02/24/1986SE |
| K860202 | Model 327D, Series R Unipolar Cardiac Pulse Gener.DXY · Traditional | 02/24/1986SE |
| K854919 | Bipolar Cardiac Pulse Generator with TelemetryDXY · Traditional | 12/19/1985SE |
| K854132 | Cook Pacemaker 332T, Series R Bipolar Cardiac PulsDXY · Traditional | 12/03/1985SE |
Questions and answers
When was Model P In-Line Bipolar Endocardial Tined Lead cleared by the FDA?
Model P In-Line Bipolar Endocardial Tined Lead (K915188) received a 510(k) decision of Unknown on September 11, 1992, 298 days after the submission was received.
What is the product code of K915188?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.