# Coeur Laboratories, Inc.

- Location (FDA's records): Raleigh, NC
- FDA decisions: 10 (1983–1997): 10 510(k) clearances
- Product codes: DXT (5), KOD (2), DTX (1), GIO (1), FMF (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Coeur, Inc.: 7 (https://510kreport.com/company/coeur)

## Its most-cited devices
- K960965: Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211 (1996), cited by 3
- K965214: Coeur Front Load Injector Retrofit Kit (C859-0002) (1997), cited by 2
- K971712: Coeur 130 ML Angiographic Syringe (1997), cited by 2

## Recent decisions
- K971712: Coeur 130 ML Angiographic Syringe (Oct 8, 1997)
- K965214: Coeur Front Load Injector Retrofit Kit (C859-0002) (Mar 28, 1997)
- K960965: Front Load Injector Turret Model 859-0001/200 ML Front Load Syringe Model 853-0211 (Sep 12, 1996)
- K890292: Pca-10, 10CC Disp. Angiography Control Syringe (Jun 22, 1989)
- K885138: Capillary Tube, Blood Collection (Feb 7, 1989)
- K885202: 16 Long Catheter W/Adapter, 14 FR and 12 FR (Jan 31, 1989)
- K881646: Urological Catheter (Jun 16, 1988)
- K874579: Coeur Control Syringe (Jan 19, 1988)

Source page: https://510kreport.com/company/coeur-laboratories