Sims Portex Anesthesia Catheter
FDA 510(k) K994275 · Sims Portex, Inc.
510(k) numberK994275
Submission
- Device name
- Sims Portex Anesthesia Catheter
- Applicant
- Sims Portex, Inc.
Keene, NH, US - Received
- December 20, 1999
- Decision date
- February 22, 2000
- 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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Questions and answers
When was Sims Portex Anesthesia Catheter cleared by the FDA?
Sims Portex Anesthesia Catheter (K994275) received a 510(k) decision of Substantially Equivalent on February 22, 2000, 64 days after the submission was received.
What is the product code of K994275?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.