Avi Model 2012, 1.2 Micron Filter IV Administra.
FDA 510(k) K896161 · 3M Company
510(k) numberK896161
Submission
- Device name
- Avi Model 2012, 1.2 Micron Filter IV Administra.
- Applicant
- 3M Company
St. Paul, MN, US - Received
- October 24, 1989
- Decision date
- January 11, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
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| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
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| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
| K241710 | 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-reader 490…FRC · Traditional | 09/12/2024SE |
| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was Avi Model 2012, 1.2 Micron Filter IV Administra. cleared by the FDA?
Avi Model 2012, 1.2 Micron Filter IV Administra. (K896161) received a 510(k) decision of Substantially Equivalent on January 11, 1990, 79 days after the submission was received.
What is the product code of K896161?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.