Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing
FDA 510(k) K122756 · Penumbra, Inc.
510(k) numberK122756
Submission
- Device name
- Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- September 7, 2012
- Decision date
- October 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | 06/10/2026SE |
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| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | 02/05/2026SE |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…QEW · Traditional | 10/16/2025SE |
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| K242104 | Penumbra System (Reperfusion Catheter RED 72)NRY · Traditional | 02/13/2025SE |
| K242033 | Access25 Delivery MicrocatheterQJP · Traditional | 12/11/2024SE |
| K242520 | Element Vascular Access SystemDYB · Traditional | 11/20/2024SE |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | 09/25/2024SE |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6XQEW · Special | 09/03/2024SE |
Questions and answers
When was Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing cleared by the FDA?
Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing (K122756) received a 510(k) decision of Substantially Equivalent on October 2, 2012, 25 days after the submission was received.
What is the product code of K122756?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.