Emergency Infusion Device
FDA 510(k) K840455 · Arrow Intl., Inc.
510(k) numberK840455
Submission
- Device name
- Emergency Infusion Device
- Applicant
- Arrow Intl., Inc.
Mchenry, IL, US - Received
- February 2, 1984
- Decision date
- May 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Emergency Infusion Device cleared by the FDA?
Emergency Infusion Device (K840455) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 111 days after the submission was received.
What is the product code of K840455?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.