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FDA 510(k)

ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.

K-Number: K890772 · 1989-05-10

ApplicantBoston Scientific Corp
Decision Date1989-05-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. 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 1989-05-10 under 510(k) number K890772. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.?

ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. is a medical device that received FDA 510(k) clearance on 1989-05-10. The listed applicant is Boston Scientific Corp. The 510(k) number is K890772.

When did ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. receive FDA 510(k) clearance?

ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. received FDA 510(k) clearance on 1989-05-10, under 510(k) number K890772.

Who is the listed applicant for ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.?

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 ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.?

The FDA product code for ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. is IYO.

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Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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