Ivac PC Anifuser
FDA 510(k) K915063 · Y
510(k) numberK915063
Submission
- Device name
- Ivac PC Anifuser
- Applicant
- Y
San Diego, CA, US - Received
- November 8, 1991
- Decision date
- June 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEA – Pump, Infusion, Pca
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162165 | ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent…MEA · Traditional | Summit Medical Products, Inc. | 08/29/2017SE |
| K170982 | CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion…MEA · Traditional | Smiths Medical Ads, Inc. | 08/24/2017SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | Hospira, Inc. | 04/08/2016SE |
| K130394 | Cadd -Solis Ambulatory Infusion Pump, Version 3.0MEA · Traditional | Smiths Medical Asd, Inc. | 12/09/2013SE |
| K092313 | Perfusor Space Infusion Syringe Pump SystemMEA · Traditional | B.Braun Medical, Inc. | 11/04/2009SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | Smiths Medical MD, Inc. | 03/07/2008SE |
| K051253 | Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with…MEA · Traditional | Baxter Healthcare Corp | 07/15/2005SE |
| K043299 | Medley Pca Module, Model 8120MEA · Traditional | Alaris Medical Systems, Inc. | 12/10/2004SE |
| K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System…MEA · Special | Hospira, Inc. | 12/06/2004SE |
| K042800 | Lifecare Pca Infusion System with Hospira Mednet SoftwareMEA · Traditional | Hospira, Inc. | 10/18/2004SE |
More from Hospira, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K955846 | Model 2082 Temp Plus III Thermometer/Model 2087 Temp Plus III Wall Mount ThermometerFLL · Traditional | 10/01/1996SE |
| K960280 | Ivac Needle Free Valve Administration SetsFPA · Traditional | 04/04/1996SE |
| K953225 | Ivac Ball Valce Admin. SetsFPA · Traditional | 09/27/1995SE |
| K934095 | Ivac Vented Syringe Adapter Administration SetsFPA · Traditional | 08/10/1994SE |
| K940897 | Ivac Needleless Infection Valve Administration SetFPA · Traditional | 06/22/1994SE |
| K931550 | Ez Administration SetFPA · Traditional | 01/10/1994SE |
| K932544 | Ivac Space Saver Volumetric Pump, Model 599FRN · Traditional | 10/12/1993SE |
| K931549 | Model EZ-1 Sing CHAN/EZ-2 Dual Channel Infus PumpFRN · Traditional | 10/12/1993SE |
| K922115 | Ivac Needleless Injection ValveFPA · Traditional | 10/12/1993SE |
| K930781 | Infusion PumpFRN · Traditional | 08/19/1993SE |
Questions and answers
When was Ivac PC Anifuser cleared by the FDA?
Ivac PC Anifuser (K915063) received a 510(k) decision of Substantially Equivalent on June 3, 1992, 208 days after the submission was received.
What is the product code of K915063?
The FDA product code is MEA – Pump, Infusion, Pca, a Class II (moderate risk) device regulated under 21 CFR 880.5725.