Stediflo Infusion Set
FDA 510(k) K832739 · Dravon Medical, Inc.
510(k) numberK832739
Submission
- Device name
- Stediflo Infusion Set
- Applicant
- Dravon Medical, Inc.
Mchenry, IL, US - Received
- August 15, 1983
- Decision date
- December 22, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K811851 | S-610 Shunt Adaptor SetKNR · Traditional | 08/31/1981SE |
| K800435 | Hemostatic/Tube Occluding ForcepsGEN · Traditional | 03/12/1980SE |
| K782058 | Catheter, Beta-Cap-PeritonealFJS · Traditional | 02/27/1979SE |
| K782057 | Catheter, Radiopaque TenckhoffFJS · Traditional | 02/27/1979SE |
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Questions and answers
When was Stediflo Infusion Set cleared by the FDA?
Stediflo Infusion Set (K832739) received a 510(k) decision of Substantially Equivalent on December 22, 1983, 129 days after the submission was received.
What is the product code of K832739?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.