NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML— 510(k) K113198
Substantially EquivalentNavilyst Medical, Inc.
FDA 510(k) clearance K113198 for NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML, Substantially Equivalent on 2011-11-28. Applicant: Navilyst Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Navilyst 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
- Special
- Location
- Marlborough, MA, US
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- K251788 — Extension tube
More clearances from Navilyst Medical, 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 →
Recalls naming K113198
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 K113198.
Data sourced from openFDA. This site is unofficial and independent of the FDA.