# K875196: Disposable Coronary Control Syringe 12CC

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Feb 11, 1988 after 56 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022735: Microplex Coil System (MCS) and Hydrocoil Embolic System (Hes) with the Hydrolink Syringe Kit (2002), 0 descendants of its own

## Recalls of this device
- Mar 23, 2017 · Class II · Z-1889-2017: Merit Medical Systems announces a voluntary field action for the 1mL Medallion¿ Syringes due to a defect with the syringe plunger tip.
- Mar 13, 2014 · Class II · Z-1320-2014: The products are labeled as sterile but were not sterilized.
- Sep 9, 2010 · Not classified · Z-0063-2011: Small holes in the packaging may render the product non-sterile.
- Sep 9, 2010 · Not classified · Z-0066-2011: Small holes in the packaging may render the product non-sterile.
- Sep 9, 2010 · Not classified · Z-0062-2011: Small holes in the packaging may render the product non-sterile.
- Sep 9, 2010 · Not classified · Z-0061-2011: Small holes in the packaging may render the product non-sterile.
- Sep 9, 2010 · Not classified · Z-0064-2011: Small holes in the packaging may render the product non-sterile.
- Sep 9, 2010 · Not classified · Z-0065-2011: Small holes in the packaging may render the product non-sterile.
- Sep 29, 2009 · Not classified · Z-0520-2010: Potential sterility breach caused by excessive shipment damage.
- Jul 9, 2008 · Not classified · Z-2368-2008: Control Syringes may be non-sterile due to holes in the packaging.
- Jul 9, 2008 · Not classified · Z-2367-2008: Control Syringes may be non-sterile due to holes in the packaging.
- Jul 9, 2008 · Not classified · Z-2366-2008: Control Syringes may be non-sterile due to holes in the packaging.
- Sep 14, 2004 · Not classified · Z-0048-05: Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- Sep 14, 2004 · Not classified · Z-0049-05: Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
- May 16, 2003 · Not classified · Z-0912-03: Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

Source page: https://510kreport.com/device/K875196
Methodology: https://510kreport.com/methodology