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FDA 510(k)

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR

K-Number: K974648 · 1998-08-04

ApplicantSulzer Carbomedics, Inc.
Decision Date1998-08-04
Product CodeMOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Carbomedics, Inc.. It received FDA 510(k) clearance on 1998-08-04 under 510(k) number K974648. The device is classified under product code MOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR?

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR is a medical device that received FDA 510(k) clearance on 1998-08-04. The listed applicant is Sulzer Carbomedics, Inc.. The 510(k) number is K974648.

When did SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR receive FDA 510(k) clearance?

SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR received FDA 510(k) clearance on 1998-08-04, under 510(k) number K974648.

Who is the listed applicant for SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR?

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

What is the FDA product code for SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR?

The FDA product code for SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR is MOP.

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Other records listing Sulzer Carbomedics, 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.

K023185ANNULOFLEX ANNUOPLASTY SYSTEM, MODEL AF 800K013022SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESISK021051ANNULOFLO SYSTEM, MITRAL MODEL AR700K002007SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESISK993288SULZER CARBOMEDICS CARDIOFIX PERICARDIUMK992056ANNULOFLEX ANNULOPLASTY SYSTEM, MODEL AF800

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Related Devices (Code: MOP)

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.

K980016MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEGenzyme Surgical Product (Genzyme Biosurgery)K960923CARBOMEDICS MITRAL ROTATORCarbomedics, Inc.K951368CARBOMEDICS EXENDED MITRAL ROTATORCarbomedics, Inc.

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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