FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
K Number: K223929
·
Decision Jun 1, 2023
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
1
Review Days
153
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Basic Information
- Device Name
- Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
- K Number
- K223929
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innova Vascular, Inc.
- Date Received
- December 30, 2022
- Decision Date
- June 1, 2023
- Product Code
- QEW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | FDA class 2 | Cardiovascular |
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