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FDA 510(k)

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM

K-Number: K924712 · 1992-12-08

ApplicantHearing Tech, Inc.
Decision Date1992-12-08
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Tech, Inc.. It received FDA 510(k) clearance on 1992-12-08 under 510(k) number K924712. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM?

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 1992-12-08. The listed applicant is Hearing Tech, Inc.. The 510(k) number is K924712.

When did ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM receive FDA 510(k) clearance?

ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM received FDA 510(k) clearance on 1992-12-08, under 510(k) number K924712.

Who is the listed applicant for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM?

The FDA 510(k) record lists Hearing Tech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM?

The FDA product code for ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM is MCW.

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Other records listing Hearing Tech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K941587HEARING TECHK905680543 SERIES BTEK903295ESCORT ITCK903023HERITAGE III (HTC) ITC TYPE HEARING AIDK870723HEARTECH HFX, HEARING AIDK870350ESCORT EC CUSTOM IN-THE-EAR HEARING AID

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Related Devices (Code: MCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260244Auryon Atherectomy SystemEximo MedicalK250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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