Fenestrated Infusion Catheter
FDA 510(k) K024190 · Promedic, Inc.
510(k) numberK024190
Submission
- Device name
- Fenestrated Infusion Catheter
- Applicant
- Promedic, Inc.
Mccordsville, IN, US - Received
- December 19, 2002
- Decision date
- March 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K023579 | Gas Sampling LinesCCK · Traditional | 01/28/2003SE |
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Questions and answers
When was Fenestrated Infusion Catheter cleared by the FDA?
Fenestrated Infusion Catheter (K024190) received a 510(k) decision of Substantially Equivalent on March 17, 2003, 88 days after the submission was received.
What is the product code of K024190?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.