Trac-Wright Trac 10 Catheter
FDA 510(k) K915238 · Dow Corning Wright
510(k) numberK915238
Submission
- Device name
- Trac-Wright Trac 10 Catheter
- Applicant
- Dow Corning Wright
Miami Lakes, FL, US - Received
- November 21, 1991
- Decision date
- February 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K932210 | Ortholoc Advantim Revision Femoral ComponentJWH · Traditional | 09/07/1994SN |
| K932911 | Ortholoc Advantim L.S. Tibial ComponentJWH · Traditional | 06/30/1994SN |
| K934354 | Lacey All Polyethylene Tibial ComponentJWH · Traditional | 06/03/1994SE |
| K932222 | SLT Femoral HeadLZO · Traditional | 05/27/1994SE |
| K932858 | Ortholoc Advantim Tibial Base ComponentJWH · Traditional | 02/16/1994SE |
| K930228 | Ortholoc Advantim Tibial Stem 5 DegreeJWH · Traditional | 11/30/1993SE |
| K925900 | Lacey Revision Femoral ComponentJWH · Traditional | 08/24/1993SE |
| K930189 | Ortholoc(R) Advantim(Tm) Posterior Stab Femor CompJWH · Traditional | 08/06/1993SN |
| K930188 | Ortholoc(R) Advantim(Tm) Femoral ComponentJWH · Traditional | 08/03/1993SE |
| K930190 | Ortholoc(R) Advantim(Tm) Non-Por Coat Femor CompJWH · Traditional | 08/02/1993SE |
Questions and answers
When was Trac-Wright Trac 10 Catheter cleared by the FDA?
Trac-Wright Trac 10 Catheter (K915238) received a 510(k) decision of Substantially Equivalent on February 19, 1992, 90 days after the submission was received.
What is the product code of K915238?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.