Rapid-Fill Tubeset, Model 90005
FDA 510(k) K022523 · Baxa Corp.
510(k) numberK022523
Submission
- Device name
- Rapid-Fill Tubeset, Model 90005
- Applicant
- Baxa Corp.
Englewood, CO, US - Received
- July 30, 2002
- Decision date
- August 12, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K983321 | Microfuse Dual Rate InfuserFRN · Special | 10/06/1998SE |
| K951871 | Piston SyringeFMF · Traditional | 06/21/1995SE |
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Questions and answers
When was Rapid-Fill Tubeset, Model 90005 cleared by the FDA?
Rapid-Fill Tubeset, Model 90005 (K022523) received a 510(k) decision of Substantially Equivalent on August 12, 2002, 13 days after the submission was received.
What is the product code of K022523?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.