Psi-Tec Peristaltic Infiltration Pump
FDA 510(k) K040149 · Byron Medical
510(k) numberK040149
Submission
- Device name
- Psi-Tec Peristaltic Infiltration Pump
- Applicant
- Byron Medical
Tucson, AZ, US - Received
- January 23, 2004
- Decision date
- June 3, 2004
- 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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| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
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More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K001803 | Accelerator Reciprocating CannulaQPB · Traditional | 08/04/2000SE |
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| K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationFRN · Traditional | 06/16/1998SE |
| K980392 | Psi-Tec AspiratorBTA · Traditional | 03/05/1998SE |
| K974295 | Byron Medical Aspiration and Infiltration/Irrigation TubingKGZ · Traditional | 02/10/1998SE |
| K973133 | Big Bag 3000 Pressure InfusorFRN · Traditional | 09/12/1997ST |
| K934179 | Disposable Bag DecanterKPE · Traditional | 05/23/1994SE |
| K934233 | Zara Zone IV Malar Implant ModificationLZK · Traditional | 02/03/1994SE |
| K933670 | Biopsy Punch, SurgicalEME · Traditional | 01/07/1994SE |
Questions and answers
When was Psi-Tec Peristaltic Infiltration Pump cleared by the FDA?
Psi-Tec Peristaltic Infiltration Pump (K040149) received a 510(k) decision of Substantially Equivalent on June 3, 2004, 132 days after the submission was received.
What is the product code of K040149?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.