Swabbable Cap, Model 60205
FDA 510(k) K070163 · Baxa Corp.
510(k) numberK070163
Submission
- Device name
- Swabbable Cap, Model 60205
- Applicant
- Baxa Corp.
Englewood, CO, US - Received
- January 17, 2007
- Decision date
- August 3, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODI – Administration Set Docking Station
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
Temporary closing IV administration set. Temporary aseptic closure of the male Luer connector of the IV tubing in between uses for the life of the administration set.
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Questions and answers
When was Swabbable Cap, Model 60205 cleared by the FDA?
Swabbable Cap, Model 60205 (K070163) received a 510(k) decision of Substantially Equivalent on August 3, 2007, 198 days after the submission was received.
What is the product code of K070163?
The FDA product code is ODI – Administration Set Docking Station, a Class II (moderate risk) device regulated under 21 CFR 880.5440.