Angio-Band
FDA 510(k) K923112 · Cook, Inc.
510(k) numberK923112
Submission
- Device name
- Angio-Band
- Applicant
- Cook, Inc.
Ontario L4a 7x5, CA - Received
- June 25, 1992
- Decision date
- September 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Angio-Band cleared by the FDA?
Angio-Band (K923112) received a 510(k) decision of Substantially Equivalent on September 23, 1992, 90 days after the submission was received.
What is the product code of K923112?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.