Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002
FDA 510(k) K993564 · Possis Medical, Inc.
510(k) numberK993564
Submission
- Device name
- Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002
- Applicant
- Possis Medical, Inc.
Minneapolis, MN, US - Received
- October 21, 1999
- Decision date
- April 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
More from Eximo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K133629 | Angiojet Ultra Avx Thrombectomy SetQEW · Special | 02/14/2014SE |
| K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsQEZ · Special | 06/22/2009SE |
| K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior…QEZ · Traditional | 04/08/2009SE |
| K082382 | Angiojet Ultra Avx Thrombectomy Set, Model 105039QEZ · Traditional | 12/12/2008SE |
| K081989 | Modification to Fetch Aspiration CatheterQEZ · Special | 09/26/2008SE |
| K081454 | Guarddog Occlusion Guidewire, Inflation DeviceMJN · Special | 06/13/2008SE |
| K080806 | Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608QEZ · Traditional | 04/04/2008SE |
| K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039QEZ · Traditional | 01/24/2008SE |
| K072769 | Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy SetsQEZ · Traditional | 11/14/2007SE |
| K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552QEZ · Traditional | 09/08/2007SE |
Questions and answers
When was Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002 cleared by the FDA?
Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002 (K993564) received a 510(k) decision of Substantially Equivalent on April 28, 2000, 190 days after the submission was received.
What is the product code of K993564?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.