FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
K Number: K152541
·
Decision Jan 13, 2016
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
87
Review Days
131
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Basic Information
- Device Name
- Penumbra System ACE 64 and ACE 68 Reperfusion Catheters
- K Number
- K152541
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Penumbra, Inc.
- Date Received
- September 4, 2015
- Decision Date
- January 13, 2016
- 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 Penumbra, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing) | Jun 10, 2026 | Substantially Equivalent |
| K260599 | INDIGO® Aspiration System INDIGO Link | Apr 24, 2026 | Substantially Equivalent |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Feb 5, 2026 | Substantially Equivalent |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System Lightning Bolt Aspiration Tubing | Oct 16, 2025 | Substantially Equivalent |
| 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 |