# K970388: A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Aug 14, 1997 after 192 days
- Product code: DTD (Pacemaker Lead Adaptor)
- Device class: 2
- Regulation: 21 CFR 870.3620
- 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 K902889 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902889: A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace., Biotronik, GmbH & Co. (1990) Summary page 3.

## Indications for use
Lead adapters, including silicone adapter sleeves, when used in conjunction with their accessories, provide a means of securely connecting pace/sense leads with otherwise mechanically incompatible pacemaker devices.

Source page: https://510kreport.com/device/K970388
Methodology: https://510kreport.com/methodology