Maxim PF Models 033-581/033-590
FDA 510(k) K961118 · Telectronics Pacing Systems, Inc.
510(k) numberK961118
Submission
- Device name
- Maxim PF Models 033-581/033-590
- Applicant
- Telectronics Pacing Systems, Inc.
Englewood, CO, US - Received
- March 20, 1996
- Decision date
- July 15, 1996
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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 |
|---|---|---|
| K943657 | SterilizationDTB · Traditional | 06/24/1996ST |
| K934899 | Bifurcated Lead Adaptors, 3.2MM & 5.0 MMDTD · Traditional | 05/12/1994SE |
| K926340 | New Lead Introducer Kits, Various ModelsDYB · Traditional | 05/27/1993SE |
| K914489 | New Extrusion Vendor for Polyurethane TubingDTB · Traditional | 08/17/1992SE |
| K913919 | Universal Terminal Cap, 3.2MMKFJ · Traditional | 12/31/1991SE |
| K912773 | Unipolar Upsizing AdaptorDTD · Traditional | 10/23/1991SE |
| K911273 | 100 CM Permanent Pacing Lead ModelsDTB · Traditional | 08/28/1991SE |
| K910112 | Bifurcated VS-1 to VS-1 Lead AdaptorDTD · Traditional | 02/25/1991SE |
| K903186 | Optima Series II Model 147B Single Chamber PulseDXY · Traditional | 01/18/1991SE |
| K904741 | Laserdish Poly Unipolar Ventri Lead W/Trail TinesDTB · Traditional | 01/08/1991SE |
Questions and answers
When was Maxim PF Models 033-581/033-590 cleared by the FDA?
Maxim PF Models 033-581/033-590 (K961118) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on July 15, 1996, 117 days after the submission was received.
What is the product code of K961118?
The FDA product code is DTB – Permanent Pacemaker Electrode, a Class III (high risk) device regulated under 21 CFR 870.3680.