# K912235: Models 432-03 & 433-03 Implant Endocard Pac Lead

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics, Inc.
- Decided: Sep 18, 1991 after 127 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K962174: Biplr IM EN Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07) (1996), 0 descendants of its own
- K960281: Implantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K912235
Methodology: https://510kreport.com/methodology