# K973371: Certodyn Raecg Universal Adapter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 24, 1997 after 77 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K843263 (1984). 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)
- K843263: Arrow-Johans Ecg Adaptor, Arrow Intl., Inc. (1984) Summary page 1.

## Indications for use
To aid in the accurate placement of central venous catheters using the RAECG technique.

Source page: https://510kreport.com/device/K973371
Methodology: https://510kreport.com/methodology