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FDA 510(k)

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB

K-Number: K904556 · 1991-12-18

ApplicantBoston Scientific Corp
Decision Date1991-12-18
Product CodeIOL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K904556. The device is classified under product code IOL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB?

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Boston Scientific Corp. The 510(k) number is K904556.

When did MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB receive FDA 510(k) clearance?

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB received FDA 510(k) clearance on 1991-12-18, under 510(k) number K904556.

Who is the listed applicant for MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB?

The FDA product code for MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB is IOL.

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Related Devices (Code: IOL)

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.

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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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