OZ POWER SYRINGE— 510(k) K973334
Substantially EquivalentCardiovascular Innovations
FDA 510(k) clearance K973334 for OZ POWER SYRINGE, Substantially Equivalent on 1998-04-03. Applicant: Cardiovascular Innovations. Device class: 2.
Clearance details
- Applicant
- Cardiovascular Innovations
- 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
- Dallas, TX, 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
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 →
Recalls naming K973334
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973334.
Data sourced from openFDA. This site is unofficial and independent of the FDA.