Nitroglycerin I.V. Administration Set
FDA 510(k) K833939 · Critikon Company, LLC
510(k) numberK833939
Submission
- Device name
- Nitroglycerin I.V. Administration Set
- Applicant
- Critikon Company, LLC
Walker, MI, US - Received
- November 15, 1983
- Decision date
- February 21, 1984
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K002248 | Dinamap Pro 1000 Monitor, Model 1000DXN · Traditional | 09/21/2000SE |
| K000500 | Dinamap Advanced Nibp ModuleDXN · Traditional | 05/26/2000SE |
| K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400MWI · Traditional | 02/24/2000SE |
| K982342 | Dinamap MPS Select Portable MonitorMSX · Traditional | 08/14/1998SE |
| K943709 | Dinamap Plus Vital Signs MonoitorDPS · Traditional | 06/16/1995SE |
| K942700 | Dinamap Vital Signs Monitor Models 9300 and 9320/9340MHX · Traditional | 03/01/1995SE |
| K933404 | Critikon Central Statin MonitorDPS · Traditional | 02/09/1994SE |
| K933050 | Changes to Protectiv(Tm) & Jelco(Tm) Winged CathFOZ · Traditional | 12/14/1993SE |
| K915697 | Critikon Vital Signs ModuleDXN · Traditional | 07/01/1993SE |
| K921295 | Intravenous Catheters ModificationsFGO · Traditional | 05/17/1993SE |
Questions and answers
When was Nitroglycerin I.V. Administration Set cleared by the FDA?
Nitroglycerin I.V. Administration Set (K833939) received a 510(k) decision of Substantially Equivalent on February 21, 1984, 98 days after the submission was received.
What is the product code of K833939?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.