FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
K Number: K240578
·
Decision Jul 31, 2024
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
82
Applicant Total
149
Review Days
152
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Basic Information
- Device Name
- VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
- K Number
- K240578
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3375
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B.Braun Medical, Inc.
- Date Received
- March 1, 2024
- Decision Date
- July 31, 2024
- Product Code
- DTK
- 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 |
|---|---|---|---|
| DTK | Filter, Intravascular, Cardiovascular | FDA class 2 | Cardiovascular |
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