Embolectomy Catheter(Modified)
FDA 510(k) K881455 · Cathlab Corp.
510(k) numberK881455
Submission
- Device name
- Embolectomy Catheter(Modified)
- Applicant
- Cathlab Corp.
Tustin, CA, US - Received
- April 6, 1988
- Decision date
- June 15, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXE – Catheter, Embolectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
Other 510(k)s with product code DXE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy CatheterDXE · Traditional | Edwards Lifesciences, LLC | 08/28/2024SE |
| 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 |
| K233819 | Fogarty Venous Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences, LLC | 05/22/2024SE |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy CathetersDXE · Traditional | Edwards Lifesciences | 05/20/2024SE |
| K213771 | Merlin Aspiration SystemDXE · Traditional | Mivi Neurovascular, Inc. | 01/27/2022SE |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning CatheterDXE · Special | Applied Medical Resources Corporation | 09/07/2021SE |
| 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 |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K910917 | Cathlab Silicone Biliary Balloon CatheterGCA · Traditional | 08/02/1991SE |
| K910916 | Cathlab Silicone Occlusion Balloon CatheterDQT · Traditional | 06/24/1991SE |
| K905139 | Cathlab Silicone Arterial Embolectomy CatheterDXE · Traditional | 02/25/1991SE |
| K897051 | Miller Percutaneous Angiographic/Scopic Irri. CathDQO · Traditional | 03/16/1990SE |
| K897184 | 3F and 4F Irrigation Embolectomy CathetersDXE · Traditional | 03/14/1990SE |
| K893435 | Silicone Flow-Directed Thermodilution CatheterDYG · Traditional | 09/26/1989SE |
| K893680 | Silicone Bi-Lumen Irrigation Embolectomy Cath.DXE · Traditional | 08/01/1989SE |
Questions and answers
When was Embolectomy Catheter(Modified) cleared by the FDA?
Embolectomy Catheter(Modified) (K881455) received a 510(k) decision of Substantially Equivalent on June 15, 1988, 70 days after the submission was received.
What is the product code of K881455?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.