Modified Ancor & Hi-Flex Unipolar Active Fix. Lead
FDA 510(k) K885240 · Tpl-Cordis, Inc.
510(k) numberK885240
Submission
- Device name
- Modified Ancor & Hi-Flex Unipolar Active Fix. Lead
- Applicant
- Tpl-Cordis, Inc.
Englewood, CO, US - Received
- December 21, 1988
- Decision date
- February 10, 1989
- 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 |
|---|---|---|
| K882429 | Model 255A Programmer III, W/Software Revi. 4004KRG · Traditional | 07/22/1988SE |
| K880898 | Multicor and PacemakersDXY · Traditional | 05/06/1988SE |
| K880432 | Vicor Pacer, Model 410ADXY · Traditional | 02/22/1988SE |
| K873158 | Modified Multicor and Omni-Stanicor PacemakersDXY · Traditional | 01/07/1988SE |
| K873202 | Vicor, Model 410ADXY · Traditional | 10/15/1987SE |
Questions and answers
When was Modified Ancor & Hi-Flex Unipolar Active Fix. Lead cleared by the FDA?
Modified Ancor & Hi-Flex Unipolar Active Fix. Lead (K885240) received a 510(k) decision of Substantially Equivalent on February 10, 1989, 51 days after the submission was received.
What is the product code of K885240?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.