DISPOSABLE HEMOSTATIC Y-CONNECTORS— 510(k) K113132
Substantially EquivalentCoeur, Inc.
FDA 510(k) clearance K113132 for DISPOSABLE HEMOSTATIC Y-CONNECTORS, Substantially Equivalent on 2012-01-20. Applicant: Coeur, Inc.. Device class: 2.
Clearance details
- Applicant
- Coeur, Inc.
- Product code
- Code DTL
- Device class
- Class 2
- Regulation
- 21 CFR 870.4290
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lebanon, TN, US
Recent devices under product code DTL
view allMore clearances from Coeur, Inc.
view all- K170431 — CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram Tip
- K161471 — MR Syringe Dual Pack for Solaris Injectors
- K150902 — 330psi Extension Y-Line with Dual Check Valve
- K142745 — 125mL CT Syringe
- K140469 — MR SYRINGE DUAL PACK
Adverse events under product code DTL
product code DTL- Malfunction
- 770
- Total
- 770
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.