Pull Tab Squeeze Flush
FDA 510(k) K070979 · Icu Medical, Inc.
510(k) numberK070979
Submission
- Device name
- Pull Tab Squeeze Flush
- Applicant
- Icu Medical, Inc.
Salt Lake City, UT, US - Received
- April 6, 2007
- Decision date
- September 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRA – Catheter, Continuous Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1210
- Specialty
- Cardiovascular
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Questions and answers
When was Pull Tab Squeeze Flush cleared by the FDA?
Pull Tab Squeeze Flush (K070979) received a 510(k) decision of Substantially Equivalent on September 19, 2007, 166 days after the submission was received.
What is the product code of K070979?
The FDA product code is KRA – Catheter, Continuous Flush, a Class II (moderate risk) device regulated under 21 CFR 870.1210.