# K962141: Volume Control Syringe Model VCD-Syr-10

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Mar 19, 1997 after 289 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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. The FDA summary names its predicate without a number.
- (no number) Angiographic Injector Syringe (Angeion): named in the summary without a submission number

## Indications for use
The Volume Control Delivery Syringe is used for the controlled inflation of balloon catheters during angioplasty procedures.

Source page: https://510kreport.com/device/K962141
Methodology: https://510kreport.com/methodology