Rotablator Rotational Angioplasty System
FDA 510(k) K924712 · Hearing Tech, Inc.
510(k) numberK924712
Submission
- Device name
- Rotablator Rotational Angioplasty System
- Applicant
- Hearing Tech, Inc.
Bellevue, WA, US - Received
- September 18, 1992
- Decision date
- December 8, 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K941587 | Hearing TechESD · Traditional | 06/24/1994SE |
| K905680 | 543 Series BteESD · Traditional | 03/08/1991SE |
| K903295 | Escort ItcESD · Traditional | 09/05/1990SE |
| K903023 | Heritage III (HTC) Itc Type Hearing AidESD · Traditional | 07/27/1990SE |
| K870723 | Heartech HFX, Hearing AidESD · Traditional | 03/20/1987SE |
| K870350 | Escort Ec Custom In-The-Ear Hearing AidESD · Traditional | 03/11/1987SE |
| K854315 | Heartech Model in TechESD · Traditional | 01/21/1986SE |
| K853220 | Heartech Model IllusionESD · Traditional | 09/23/1985SE |
| K853219 | Heartech Model CHESD · Traditional | 09/23/1985SE |
| K853218 | Heartech Model(Htc) (Heritage)ESD · Traditional | 09/23/1985SE |
Questions and answers
When was Rotablator Rotational Angioplasty System cleared by the FDA?
Rotablator Rotational Angioplasty System (K924712) received a 510(k) decision of Substantially Equivalent on December 8, 1992, 81 days after the submission was received.
What is the product code of K924712?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.