Lemaitre Balloon Catheter with Irrigation
FDA 510(k) K992940 · Vascutech, Inc.
510(k) numberK992940
Submission
- Device name
- Lemaitre Balloon Catheter with Irrigation
- Applicant
- Vascutech, Inc.
Burlington, MA, US - Received
- August 31, 1999
- Decision date
- February 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K001621 | Dardik Carotid ShuntMJN · Traditional | 12/06/2000SE |
| K992942 | Lemaitre Occlusion CatheterMJN · Traditional | 04/13/2000SE |
| K992933 | Lemaitre Irrigation CatheterDXE · Traditional | 03/08/2000SE |
| K992934 | Lemaitre Venous Thrombectomy CatheterDXE · Traditional | 03/01/2000SE |
| K992941 | Lemaitre Biliary CatheterLQR · Traditional | 01/12/2000SE |
| K992368 | Lemaitre Embolectomy CatheterDXE · Traditional | 12/09/1999SE |
| K980723 | 2.0MM Expandable Lemaitre Valvulotome (Elv 2.0- GNT)MGZ · Traditional | 02/12/1999SE |
| K946352 | Lemaitre Valvulotome IIMGZ · Traditional | 06/21/1995SE |
| K932009 | The Samuels Retrograd ValvulotomeMGZ · Traditional | 09/21/1993SE |
| K932184 | Sterile Lemaitre Glow 'N Tell TapeKFX · Traditional | 07/22/1993SE |
Questions and answers
When was Lemaitre Balloon Catheter with Irrigation cleared by the FDA?
Lemaitre Balloon Catheter with Irrigation (K992940) received a 510(k) decision of Substantially Equivalent on February 22, 2000, 175 days after the submission was received.
What is the product code of K992940?
The FDA product code is DXE – Catheter, Embolectomy, a Class II (moderate risk) device regulated under 21 CFR 870.5150.