# K960281: Implantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory - Pathway: 510(k) (Traditional) - Applicant: Intermedics, Inc. - Decided: Jun 18, 1996 after 151 days - Product code: DTB (Permanent Pacemaker Electrode) - Device class: 3 - Regulation: 21 CFR 870.3680 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K862276 (1986). 10 ancestors in all. No later device cites it as a predicate yet. 0 of 11 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K883602: Biopore VS.1 Endocardial Inter Implant Pacing Lead, Intermedics, Inc. (1988) Summary page 8. - K890412: Models 430-07 & 431-07 Implantable Pacing Leads, Intermedics, Inc. (1989) Summary page 8. - K902672: Intermedics 430-07 Bipol Implant Endocard Pac Lead, Intermedics, Inc. (1991) Summary page 8. - K890411: Models 432-03 & 433-03 Implantable Pacing Leads, Intermedics, Inc. (1989) Summary page 8. - K912235: Models 432-03 & 433-03 Implant Endocard Pac Lead, Intermedics, Inc. (1991) Summary page 8. - K862276: Model 435-02 Cardifix Implantable Pacing Lead, Intermedics, Inc. (1986) Summary page 8. - K922972: Models 438-05 and 435-05 Implantable Pacing Lead, Intermedics, Inc. (1993) Summary page 8. - K922042: Cardifix Endocardial Pacing Lead, Intermedics, Inc. (1993) Summary page 8. - K874531: Polyflex (R) Epicardial 439-04 Implant Pacing Lead, Intermedics, Inc. (1988) Summary page 9. - K880551: Model 439-07 and 439-09 Lifeline Myocardial Lead, Intermedics, Inc. (1988) Summary page 9. ## Indications for use The indications for use of Intermedics Models 431-04, 431-07, 433-02, 433-03, 435-02, 435-05, 435-07, 435-08, 437-02, and 437-07 endocardial pacing leads, model 439-04 epicardial pacing lead, model 439-07 myocardial pacing lead, implantable accessory models 365-07, 365-09, 365-14, 365-17, 365-19, 365-22, 365-33, 365-34, 36544, 365-49, 366-13, 366-15, 366-27, 366-28, 366-29, and 366-30, and non-implantable accessory models 365-62, 365-77, 365-29, 366-02, 366-17, and 367:01, manufactured using a Chlorofluorocarbon (CFC) Free process, are identical to those for the commercially available leads and accessories with the same model numbers manufactured using Freon-TMS. Pacing leads and accessories are intended for use with implantable cardiac palse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony. Active fixation leads are specifically indicated for use in cases where passive-fixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease. Suture-on epicardial leads (model 439-04) and screw-on (sutureless) myocardial leads (model 439-07), placed on the outside of the heart, are indicated for use when cardiac pacing is indicated and a suture-on lead is preferred, or when an endocardial lead cannot achieve satisfactory results. Such leads are particularly well suited to patients whose age or heart condition requires that the potential for lead dislodgment be minimized (i.e. patients who have not reached full physical maturity) and patients who may require cardiac pacing following open-chest surgery. Source page: https://510kreport.com/device/K960281 Methodology: https://510kreport.com/methodology