Titan Driver 60CC, 30 Minute Administration Set
FDA 510(k) K953028 · I-Flow Corp.
510(k) numberK953028
Submission
- Device name
- Titan Driver 60CC, 30 Minute Administration Set
- Applicant
- I-Flow Corp.
Irvine, CA, US - Received
- June 29, 1995
- Decision date
- September 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEB – Pump, Infusion, Elastomeric
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K240624 | InfuLifeMEB · Traditional | First Medical Source, LLC | 11/05/2024SE |
| K242152 | SMARTeZ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)MEB · Special | Epic Medical Pte. , Ltd. | 10/07/2024SE |
| K181360 | ON-Q* Pump with BolusMEB · Traditional | Halyard Health | 03/22/2019SE |
| K151650 | SMARTez elastomeric infusion pumpMEB · Traditional | Epic Medical Pte. , Ltd. | 04/04/2016SE |
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | I-Flow, LLC | 02/03/2014SE |
| K131247 | Multibolus II Disposable Pain Management SystemMEB · Traditional | Mfs - Medical Flow Systems, Ltd. | 08/14/2013SE |
| K090300 | Modification to AutofuserMEB · Special | Ace Medical Us, LLC | 04/30/2009SE |
| K081905 | Accuflow and Accuflux Elastomeric Infusion PumpMEB · Traditional | Westmed, Inc. | 07/15/2008SE |
| K071532 | Alpha Infusion Pump, Model A200, A450MEB · Traditional | Advanced Infusion, Inc. | 02/19/2008SE |
More from Advanced Infusion, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131249 | On-Q Painbuster, On-Q C-Bloc, Homepump Eclipse, Homepump C-SeriesMEB · Traditional | 02/03/2014SE |
| K063530 | On-Q, Painbuster, C-Bloc, Select-A-Flow, Ondemand, Homepump, Eclipse, C-Series, One-Step…MEB · Special | 01/26/2007SE |
| K063234 | On-Q IntroducersBSO · Abbreviated | 11/21/2006SE |
| K051401 | On-Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterBSO · Traditional | 11/30/2005SE |
| K052117 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Block, Homepump, Easypump)MEB · Special | 09/09/2005SE |
| K043456 | Modification to Soaker CatheterBSO · Special | 01/11/2005SE |
| K040337 | I-Flow Elastomeric Pump (On-Q, Painbuster, C-Bloc, Homepump)MEB · Traditional | 05/24/2004SE |
| K023883 | Homepump, Eclipse, C-Series, Painbuster, C-Bloc, On-Q, Easypump, KvoMEB · Special | 12/20/2002SE |
| K023827 | Paragon Infusion System with BolusFRN · Special | 12/13/2002SE |
| K023318 | I-Flow Elastomeric Pump with BolusMEB · Special | 10/18/2002SE |
Questions and answers
When was Titan Driver 60CC, 30 Minute Administration Set cleared by the FDA?
Titan Driver 60CC, 30 Minute Administration Set (K953028) received a 510(k) decision of Substantially Equivalent on September 28, 1995, 91 days after the submission was received.
What is the product code of K953028?
The FDA product code is MEB – Pump, Infusion, Elastomeric, a Class II (moderate risk) device regulated under 21 CFR 880.5725.