Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
FDA 510(k) K202049 · Applied Medical Resources Corporation
510(k) numberK202049
Submission
- Device name
- Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
- Applicant
- Applied Medical Resources Corporation
Rancho Santa, CA, US - Received
- July 24, 2020
- Decision date
- September 7, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXE – Catheter, Embolectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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| K241330 | Fogarty Fortis Arterial Embolectomy CatheterDXE · Traditional | Edwards Lifesciences | 07/02/2024SE |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate ValveDXE · Traditional | Edwards Lifesciences | 05/22/2024SE |
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| K213771 | Merlin Aspiration SystemDXE · Traditional | Mivi Neurovascular, Inc. | 01/27/2022SE |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon ProbeDXE · Traditional | Edwards Lifesciences, LLC | 06/12/2020SE |
| K163031 | Bunegin-Albin Air Aspiration SetDXE · Traditional | Cook Incorporated | 07/27/2017SE |
| K163353 | Needle's Eye Snare Retrieval Set - 54cmDXE · Special | Cook Incorporated | 07/11/2017SE |
| K152335 | Export Advance Aspiration CatheterDXE · Special | Medtronic, Inc. | 09/18/2015SE |
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Questions and answers
When was Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter cleared by the FDA?
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (K202049) received a 510(k) decision of Substantially Equivalent on September 7, 2021, 410 days after the submission was received.
What is the product code of K202049?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.