Bioteque Scalp Vein Set
FDA 510(k) K012526 · Bioteque Corp.
510(k) numberK012526
Submission
- Device name
- Bioteque Scalp Vein Set
- Applicant
- Bioteque Corp.
Flaggstaff, AZ, US - Received
- August 6, 2001
- Decision date
- September 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | 12/22/2025SE |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-seriesFGE · Traditional | 04/13/2022SE |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type)FGE · Traditional | 10/09/2020SE |
| K150932 | Sheath IntroducerDRE · Traditional | 07/22/2016SE |
| K102633 | Bioteq Angiographic CatheterDQO · Traditional | 09/09/2011SE |
| K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockFGE · Traditional | 02/14/2005SE |
| K033210 | Bioteq Double Pigtail Ureteral Stent SetFAD · Traditional | 12/30/2004SE |
| K032292 | Bioteque A.V. Fistula Needle Set with Safety FlexFOZ · Traditional | 03/22/2004SE |
| K013634 | Bioteque 3 in 1 Hemodialysis Blood Tubing PackFJK · Traditional | 07/09/2002SESK |
| K002449 | Bioteq I.V. (Intravenous) SetFPA · Traditional | 12/22/2000SE |
Questions and answers
When was Bioteque Scalp Vein Set cleared by the FDA?
Bioteque Scalp Vein Set (K012526) received a 510(k) decision of Substantially Equivalent on September 14, 2001, 39 days after the submission was received.
What is the product code of K012526?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.