Polysafe CCS Trifix Endocardial Pacing Lead SV-107
FDA 510(k) K853446 · Cardiac Control Systems, Inc.
510(k) numberK853446
Submission
- Device name
- Polysafe CCS Trifix Endocardial Pacing Lead SV-107
- Applicant
- Cardiac Control Systems, Inc.
Palm Coast, FL, US - Received
- August 16, 1985
- Decision date
- January 13, 1986
- 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 |
|---|---|---|
| K971775 | Interim Av Shaped Temporary Pacing Catheter Model INT-AV610LDF · Traditional | 12/29/1997SE |
| K946188 | CCDS Maestro(R) II Series 200 Cadiac PacemakerDXY · Traditional | 05/15/1995ST |
| K950210 | CCS Maestro(R) II Series 200 Models 235 and 227 Cardiac PacemakerDXY · Traditional | 05/03/1995ST |
| K923868 | CCS Maestro II Series 200 Cardiac PacemakerDXY · Traditional | 05/14/1993SE |
| K905824 | Maestro(R) Series 100/200 Cardiac S/Chamb PacemakeDXY · Traditional | 05/16/1991SE |
| K904941 | Maestro Series 100/200 Cardiac Single Chamber PaceDXY · Traditional | 01/03/1991SE |
| K895110 | Maestro Pacemaker Test MagnetDTG · Traditional | 09/26/1989SE |
| K884023 | Maestro(R) Series 100/200 Single Chamber PacemakerDXY · Traditional | 10/17/1988SE |
| K884024 | Polysafe(Tm) Implantable Pacing LeadDTB · Traditional | 10/14/1988SE |
| K883015 | Polysafe Implant. Pacing Leads W/Trabeculok TipDTB · Traditional | 10/06/1988SE |
Questions and answers
When was Polysafe CCS Trifix Endocardial Pacing Lead SV-107 cleared by the FDA?
Polysafe CCS Trifix Endocardial Pacing Lead SV-107 (K853446) received a 510(k) decision of Substantially Equivalent on January 13, 1986, 150 days after the submission was received.
What is the product code of K853446?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.