Imed Technology Intravascular Administration Set, Imed Technology Extension Set— 510(k) K150513
Substantially EquivalentImed Technology, Inc.
FDA 510(k) clearance K150513 for Imed Technology Intravascular Administration Set, Imed Technology Extension Set, Substantially Equivalent on 2015-05-28. Applicant: Imed Technology, Inc.. Device class: 2.
Clearance details
- Applicant
- Imed Technology, Inc.
- Product code
- Product code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Carrollton, TX, US
Recent devices under product code FPA
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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
More clearances from Imed Technology, Inc.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.