Graduated Adapter with Clave
FDA 510(k) K080007 · Icu Medical, Inc.
510(k) numberK080007
Submission
- Device name
- Graduated Adapter with Clave
- Applicant
- Icu Medical, Inc.
Salt Lake City, UT, US - Received
- January 2, 2008
- Decision date
- May 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZD – Catheter, Straight
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Graduated Adapter with Clave cleared by the FDA?
Graduated Adapter with Clave (K080007) received a 510(k) decision of Substantially Equivalent on May 13, 2008, 132 days after the submission was received.
What is the product code of K080007?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.