Cadd Medication Cassette Reservoir
FDA 510(k) K081156 · Smiths Medical MD, Inc.
510(k) numberK081156
Submission
- Device name
- Cadd Medication Cassette Reservoir
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- April 23, 2008
- Decision date
- July 18, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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More from B.Braun Medical, Inc.
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| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…FRN · Traditional | 08/29/2011SE |
| K101180 | Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model:…FPA · Traditional | 08/03/2010SE |
| K091181 | Lockbox for Use with Medfusion 3000 Series PumpsMRZ · Traditional | 06/12/2009SE |
| K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-Of-CareMRZ · Traditional | 12/17/2008SE |
| K080743 | Lockbox for Use with Cadd Solis Infusion PumpFRN · Traditional | 04/25/2008SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | 03/07/2008SE |
| K072955 | Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care…MRZ · Traditional | 02/13/2008SE |
| K072657 | Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access…LJT · Traditional | 12/14/2007SE |
| K072059 | Gripper Micro NeedleFMI · Traditional | 11/01/2007SE |
Questions and answers
When was Cadd Medication Cassette Reservoir cleared by the FDA?
Cadd Medication Cassette Reservoir (K081156) received a 510(k) decision of Substantially Equivalent on July 18, 2008, 86 days after the submission was received.
What is the product code of K081156?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.