Exel Butterfly Scalp Vein Set
FDA 510(k) K862491 · Exel Intl.
510(k) numberK862491
Submission
- Device name
- Exel Butterfly Scalp Vein Set
- Applicant
- Exel Intl.
Culver City, CA, US - Received
- July 1, 1986
- Decision date
- August 27, 1986
- 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
Other 510(k)s with product code FPA
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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 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| 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 |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992290 | Exel Injection Plug with CapFPA · Traditional | 02/23/2000SE |
| K963658 | Exel Avf Single NeedleFMI · Traditional | 05/05/1998SE |
| K963659 | Exel I.V. Administration SetFPA · Traditional | 12/16/1997SE |
| K926119 | Exel Huber Infusion Set Rotating WingFPA · Traditional | 08/11/1993SE |
| K904685 | Exel Huber Infusion Set Without Injection Site (Y)FPA · Traditional | 11/21/1990SE |
| K903945 | Exel A-V Fistula SetFIE · Traditional | 11/20/1990SE |
| K895770 | Exel Huber Infusion SetFPA · Traditional | 07/19/1990SE |
| K895772 | Exel Indwelling CatheterFDZ · Traditional | 02/16/1990SE |
| K895771 | Exel Spinal NeedlesFMI · Traditional | 02/16/1990SE |
| K895769 | Exel Huber NeedleFMI · Traditional | 02/16/1990SE |
Questions and answers
When was Exel Butterfly Scalp Vein Set cleared by the FDA?
Exel Butterfly Scalp Vein Set (K862491) received a 510(k) decision of Substantially Equivalent on August 27, 1986, 57 days after the submission was received.
What is the product code of K862491?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.