SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT— 510(k) K951802
Substantially EquivalentScimed Life Systems, Inc.
FDA 510(k) clearance K951802 for SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT, Substantially Equivalent on 1995-07-21. Applicant: Scimed Life Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Scimed Life Systems, 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
- Maple Grove, MN, US
Recent devices under product code DXT
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- 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 Scimed Life Systems, Inc.
view allAdverse 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.