FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXS Vecta 46 Intermediate Catheter
K Number: K202752
·
Decision Aug 27, 2021
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
76
Applicant Total
19
Review Days
340
Basic Information
- Device Name
- AXS Vecta 46 Intermediate Catheter
- K Number
- K202752
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stryker Neurovascular
- Date Received
- September 21, 2020
- Decision Date
- August 27, 2021
- Product Code
- QJP
- 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 |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
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