# K971930: BK-N Sealing Cap

- Pathway: 510(k) (Traditional)
- Applicant: Biotronik, Inc.
- Decided: Aug 14, 1997 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “K970204”, which our checks could not confirm as its predicate.

## Indications for use
BK-N Sealing Caps are intended for use as components of cardiac pacing systems. BK-N Sealing Caps provide a permanent barrier of silicone insulation between the electrical conductive elements of the implantable therapeutic device lead(s) or adapter(s) and the physiological environment. BK-N Sealing Caps are designed to accommodate lead diameters of 4F, 5F and 7F.

Source page: https://510kreport.com/device/K971930
Methodology: https://510kreport.com/methodology