Rotablator

FDA 510(k) K901206 · Heart Technology, Inc.

Substantially Equivalent

510(k) numberK901206

Submission

Device name
Rotablator
Applicant
Heart Technology, Inc.
Bellevue, WA, US
Received
March 14, 1990
Decision date
September 14, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MCW – Catheter, Peripheral, Atherectomy
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4875
Specialty
Cardiovascular

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K260244Auryon Atherectomy SystemMCW · Traditional Eximo Medical04/10/2026SE
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K250385Turbo-Elite Laser Atherectomy CatheterMCW · Special Spectranetics03/13/2025SE
K242757Rotarex Atherectomy SystemMCW · Special Bard Peripheral Vascular, Inc.01/30/2025SE
K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemMCW · Special Cardio Flow Inc.,11/05/2024SE
K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special Eximo Medical, Ltd.06/27/2024SE
K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special Cardio Flow Inc.,02/15/2024SE
K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special Eximo Medical, Ltd.12/15/2023SE
K231538FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional Cardio Flow Inc.,09/27/2023SE
K230709Auryon Atherectomy SystemMCW · Special Eximo Medical, Ltd.06/09/2023SE

More from Eximo Medical, Ltd.

510(k)DeviceDecision
K933238Rotablator, ModificationMCW · Traditional 08/24/1993SE
K914581Heart Technology WireclipDQX · Traditional 01/06/1992SE
K913450Heart Technology Rotablator WireclipMCW · Traditional 09/06/1991SE

Questions and answers

When was Rotablator cleared by the FDA?

Rotablator (K901206) received a 510(k) decision of Substantially Equivalent on September 14, 1990, 184 days after the submission was received.

What is the product code of K901206?

The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.