FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
Millipede System
K Number: K253590
·
Decision Mar 16, 2026
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
9
Review Days
119
Basic Information
- Device Name
- Millipede System
- K Number
- K253590
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Perfuze, Ltd.
- Date Received
- November 17, 2025
- Decision Date
- March 16, 2026
- 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 | ||
|---|---|---|---|
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Aug 29, 2025 | Substantially Equivalent |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set | Feb 26, 2025 | Substantially Equivalent |
| 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 |