MEDLINE ANGIOGRAPHIC CONTROL SYRINGE— 510(k) K093830
Substantially EquivalentMedline Industries, Inc.
FDA 510(k) clearance K093830 for MEDLINE ANGIOGRAPHIC CONTROL SYRINGE, Substantially Equivalent on 2011-03-03. Applicant: Medline Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Medline Industries, 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
- Mundelein, IL, US
Recent devices under product code DXT
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- K251788 — Extension tube
More clearances from Medline Industries, Inc.
view all- DEN210049 — Medline ART Skin Harvesting System
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- K223100 — Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
- K222665 — Medline UNITE® Ankle Fusion Plating System
- K213054 — Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
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.