FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Drivewire 24 Guidewire
K Number: K233791
·
Decision Jul 11, 2024
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
30
Applicant Total
3
Review Days
226
Basic Information
- Device Name
- Drivewire 24 Guidewire
- K Number
- K233791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rapid-Medical Ltd.
- Date Received
- November 28, 2023
- Decision Date
- July 11, 2024
- Product Code
- MOF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOF), ordered by most recent decision date.
CHIKAI Nexus 014
FDA 510(k)
FDA Class 2
·Cardiovascular
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Synxess Neurovascular Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Aristotle 18 Guidewire; Aristotle 24 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartGUIDE deflectable hydrophilic guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular