Element Vascular Access System
FDA 510(k) K242520 · Penumbra, Inc.
510(k) numberK242520
Submission
- Device name
- Element Vascular Access System
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- August 23, 2024
- Decision date
- November 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | 04/24/2026SE |
| 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 |
| K250079 | Ruby XL SystemKRD · Traditional | 03/14/2025SE |
| K242104 | Penumbra System (Reperfusion Catheter RED 72)NRY · Traditional | 02/13/2025SE |
| K242033 | Access25 Delivery MicrocatheterQJP · Traditional | 12/11/2024SE |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | 09/25/2024SE |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6XQEW · Special | 09/03/2024SE |
| K241399 | Indigo® Lightning Flash Aspiration System Select + CatheterQEW · Special | 06/10/2024SE |
Questions and answers
When was Element Vascular Access System cleared by the FDA?
Element Vascular Access System (K242520) received a 510(k) decision of Substantially Equivalent on November 20, 2024, 89 days after the submission was received.
What is the product code of K242520?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.