Gunther Tulip Vena Cava Filter Retrieval Set
FDA 510(k) K222254 · Cook Incorporated
510(k) numberK222254
Submission
- Device name
- Gunther Tulip Vena Cava Filter Retrieval Set
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- July 27, 2022
- Decision date
- May 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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Questions and answers
When was Gunther Tulip Vena Cava Filter Retrieval Set cleared by the FDA?
Gunther Tulip Vena Cava Filter Retrieval Set (K222254) received a 510(k) decision of Substantially Equivalent on May 16, 2023, 293 days after the submission was received.
What is the product code of K222254?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.