# K964021: Intramed Side Branch Occlusion (Sbo) System  (700095 and 700099)

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Edwards
- Decided: Mar 27, 1997 after 171 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- 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 K894459 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914523: Cri Vessel Occlusin System/Cri Occlusion Coil, Catheter Research C/O Burditt, Bowles & Radzius (1992) Summary page 1.
- K894459: Angioscope, Intramed Laboratories, Inc. (1990) Summary page 1.

## Indications for use
The Intramed® SBO System is intended for the intravascular delivery and placement of occlusion coils into tributaries during in situ saphenous vein bypass graft procedures. The angioscope within the Introducer Catheter is intended to be used for vessel visualization, specifically to visualize the lumen of the saphenous vein during the in situ procedures.

Source page: https://510kreport.com/device/K964021
Methodology: https://510kreport.com/methodology