# K963758: Code 150 Blood Component Collection Set and with Direct Draw Line

- Pathway: 510(k) (Traditional)
- Applicant: Sorin Biomedical, Inc.
- Decided: Feb 20, 1998 after 520 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Electromedics Plasma Sequestration Set: named in the summary without a submission number
- (no number) Electromedics AT-1000 Sequestration Set: named in the summary without a submission number

## Most influential descendants
- K982650: Autologous Blood Management System (Abms) (1998), 8 descendants of its own
- K020647: Dideco Electa (2002), 7 descendants of its own
- K101586: Xtra Autotransfusion System (2010), 5 descendants of its own
- K112245: XTRA (2011), 1 descendant of its own
- K241236: XTRA Collection sets; XTRA Sequestration set X (2024), 0 descendants of its own

## Indications for use
Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags. Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient. The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PPP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state. The Electronmedics PRP/PPP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.

Source page: https://510kreport.com/device/K963758
Methodology: https://510kreport.com/methodology