IV Administration Set
FDA 510(k) K871908 · Travenol Laboratories, S.A.
510(k) numberK871908
Submission
- Device name
- IV Administration Set
- Applicant
- Travenol Laboratories, S.A.
Round Lake, IL, US - Received
- May 15, 1987
- Decision date
- July 27, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K132905 | 200 Micron Blood Component Filter and Syringe AdapterBRZ · Traditional | Arteriocyte Medical Systems, Inc. | 10/04/2013SE |
| 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 |
More from Charter Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K874181 | Baxter Bedside SystemFRN · Traditional | 02/22/1988SE |
| K873894 | Continu-Flo Solution W/Check Valve 2 Y-Inject SiteFPA · Traditional | 11/05/1987SE |
| K873873 | Resubmitted Micron Transfusion FilterCAK · Traditional | 10/22/1987SE |
| K873984 | Automatic Peritoneal Dialysis Cycler Set (5C4437)KDJ · Traditional | 10/20/1987SE |
| K872364 | Hemodialysis (SPS), Model 550, Code 5M1309FII · Traditional | 10/13/1987SE |
| K872652 | Upgraded Auto Peritoneal Dialysis Cycler SystemFKX · Traditional | 09/30/1987SE |
| K870801 | Flo-Gard 6200 Volumetric Infusion/Pumping BloodFRN · Traditional | 09/04/1987SE |
| K871471 | Capillary Flow Dialyzers Models ST-12 & ST-15FJI · Traditional | 06/12/1987SE |
| K865029 | Continu-Flo Solution Admin. Set W/In-Line FilterFPB · Traditional | 04/17/1987SE |
| K870169 | Capillary Flow DialyzersFJI · Traditional | 04/06/1987SE |
Questions and answers
When was IV Administration Set cleared by the FDA?
IV Administration Set (K871908) received a 510(k) decision of Substantially Equivalent on July 27, 1987, 73 days after the submission was received.
What is the product code of K871908?
The FDA product code is BRZ – Set, Blood Transfusion, a Class II (moderate risk) device regulated under 21 CFR 880.5440.