Lockbox for Use with Medfusion 3000 Series Pumps
FDA 510(k) K091181 · Smiths Medical MD, Inc.
510(k) numberK091181
Submission
- Device name
- Lockbox for Use with Medfusion 3000 Series Pumps
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- April 23, 2009
- Decision date
- June 12, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| 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 |
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Questions and answers
When was Lockbox for Use with Medfusion 3000 Series Pumps cleared by the FDA?
Lockbox for Use with Medfusion 3000 Series Pumps (K091181) received a 510(k) decision of Substantially Equivalent on June 12, 2009, 50 days after the submission was received.
What is the product code of K091181?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.