CONTRAST MODULATION SYSTEM— 510(k) K140425
Substantially EquivalentOsprey Medical, Inc.
FDA 510(k) clearance K140425 for CONTRAST MODULATION SYSTEM, Substantially Equivalent on 2014-06-11. Applicant: Osprey Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Osprey Medical, Inc.
- Product code
- Code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minnetonka, MN, US
Recent devices under product code DXT
view all- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K252653 — ACIST Pro Diagnostic System (019304) +5 more
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Osprey Medical, Inc.
view all- K190102 — DyeVert Plus Contrast Reduction System, DyeTect Contrast Monitoring System, DyeVert Plus EZ Contrast Reduction System
- K183267 — DyeVert NG Contrast Reduction System, DyeVert PLUS EZ Contrast Reduction System, DyeTect Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert PLUS EZ Contrast Reduction System
- K181936 — DyeVert PLUS EZ Contrast Reduction System
- K171698 — Smart Syringe
- K171217 — DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
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.