FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
K Number: K250012
·
Decision Feb 26, 2025
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
96
Applicant Total
7
Review Days
55
Basic Information
- Device Name
- Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set
- K Number
- K250012
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perfuze Ltd.
- Date Received
- January 2, 2025
- Decision Date
- February 26, 2025
- Product Code
- NRY
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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Other Clearances by Perfuze Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K240711 | Zipline Access Catheter | Oct 17, 2024 | Substantially Equivalent |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Sep 20, 2024 | Substantially Equivalent |
| K233648 | Millipede 088 Access Catheter | Dec 14, 2023 | Substantially Equivalent |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Oct 18, 2023 | Substantially Equivalent |
| K231802 | Millipede 088 Access Catheter | Sep 19, 2023 | Substantially Equivalent |
| K214048 | Millipede 088 Access Catheter | Sep 20, 2022 | Substantially Equivalent |