Captus Vascular Retrieval System
FDA 510(k) K170987 · Avantec Vascular Corporation
510(k) numberK170987
Submission
- Device name
- Captus Vascular Retrieval System
- Applicant
- Avantec Vascular Corporation
Sunnyvale, CA, US - Received
- April 3, 2017
- Decision date
- August 28, 2017
- 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 Captus Vascular Retrieval System cleared by the FDA?
Captus Vascular Retrieval System (K170987) received a 510(k) decision of Substantially Equivalent on August 28, 2017, 147 days after the submission was received.
What is the product code of K170987?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.