200 Micron Blood Component Filter and Syringe Adapter
FDA 510(k) K132905 · Arteriocyte Medical Systems, Inc.
510(k) numberK132905
Submission
- Device name
- 200 Micron Blood Component Filter and Syringe Adapter
- Applicant
- Arteriocyte Medical Systems, Inc.
Hopkinton, MA, US - Received
- September 16, 2013
- Decision date
- October 4, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- BRZ – Set, Blood Transfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Other 510(k)s with product code BRZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220558 | Blood Administration SetsBRZ · Traditional | Baxter Healthcare Corporation | 11/17/2022SE |
| K210335 | Blood Administration SetBRZ · Traditional | Baxter Healthcare Corporation | 06/10/2021SE |
| K083349 | Blood Transfusion SetBRZ · Traditional | Shan Dong Wei Gao Group Medical Polymer Products | 04/10/2009SE |
| K073339 | Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm…BRZ · Traditional | Fenwal, Inc. | 03/03/2008SE |
| K041496 | Pentatrasfu Blood Transfusion SetsBRZ · Abbreviated | Pentaferte S.P.A | 06/30/2005SE |
| K050805 | 30 ML or 60 ML Pedi-Syringe FilterBRZ · Traditional | Blood Products Specialties, LLC | 06/20/2005SE |
| K050115 | Blood Hand Pump Administration SetBRZ · Traditional | Cardinal Health, Alaris Products | 04/01/2005SE |
| K023039 | Blood/Solution Administration Set, Model 33.015BRZ · Traditional | Tuta Healthcare Pty Limited | 11/07/2002SE |
| K000685 | Charter Medical Neonatal Syringe SetBRZ · Traditional | Charter Medical, Ltd. | 08/15/2000SE |
| K993120 | Modified Blood Recipient SetBRZ · Traditional | Baxter Healthcare Corp | 11/17/1999SE |
Questions and answers
When was 200 Micron Blood Component Filter and Syringe Adapter cleared by the FDA?
200 Micron Blood Component Filter and Syringe Adapter (K132905) received a 510(k) decision of Substantially Equivalent on October 4, 2013, 18 days after the submission was received.
What is the product code of K132905?
The FDA product code is BRZ – Set, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.