Rotablator, Modification

FDA 510(k) K933238 · Heart Technology, Inc.

Substantially Equivalent

510(k) numberK933238

Submission

Device name
Rotablator, Modification
Applicant
Heart Technology, Inc.
Bellevue, WA, US
Received
June 15, 1993
Decision date
August 24, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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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
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K230709Auryon Atherectomy SystemMCW · Special Eximo Medical, Ltd.06/09/2023SE

More from Eximo Medical, Ltd.

510(k)DeviceDecision
K914581Heart Technology WireclipDQX · Traditional 01/06/1992SE
K913450Heart Technology Rotablator WireclipMCW · Traditional 09/06/1991SE
K901206RotablatorMCW · Traditional 09/14/1990SE

Questions and answers

When was Rotablator, Modification cleared by the FDA?

Rotablator, Modification (K933238) received a 510(k) decision of Substantially Equivalent on August 24, 1993, 70 days after the submission was received.

What is the product code of K933238?

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