FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Indigo® Lightning Flash Aspiration System Select + Catheter
K Number: K241399
·
Decision Jun 10, 2024
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
129
Applicant Total
50
Review Days
25
Basic Information
- Device Name
- Indigo® Lightning Flash Aspiration System Select + Catheter
- K Number
- K241399
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penumbra, Inc.
- Date Received
- May 16, 2024
- Decision Date
- June 10, 2024
- Product Code
- QEW
- 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 |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | FDA class 2 | Cardiovascular |
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Other Clearances by Penumbra, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250079 | Ruby XL System | Mar 14, 2025 | Substantially Equivalent |
| K242104 | Penumbra System (Reperfusion Catheter RED 72) | Feb 13, 2025 | Substantially Equivalent |
| K242033 | Access25 Delivery Microcatheter | Dec 11, 2024 | Substantially Equivalent |
| K242520 | Element Vascular Access System | Nov 20, 2024 | Substantially Equivalent |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Sep 25, 2024 | Substantially Equivalent |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6X | Sep 3, 2024 | Substantially Equivalent |
| K233201 | MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter; MIDWAY 62 Delivery Catheter) | Mar 27, 2024 | Substantially Equivalent |
| K240030 | Indigo® Aspiration System - Lightning® Flash | Feb 2, 2024 | Substantially Equivalent |
| K230284 | Penumbra LP Coil System | Oct 25, 2023 | Substantially Equivalent |
| K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing | Feb 13, 2023 | Substantially Equivalent |