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FDA 510(k)

CVIS ULTRA-SCAN ONE IMAGING CATHETER

K-Number: K893837 · 1989-08-22

ApplicantCardiovascular Imaging Systems, Inc.
Decision Date1989-08-22
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CVIS ULTRA-SCAN ONE IMAGING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Systems, Inc.. It received FDA 510(k) clearance on 1989-08-22 under 510(k) number K893837. 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 CVIS ULTRA-SCAN ONE IMAGING CATHETER?

CVIS ULTRA-SCAN ONE IMAGING CATHETER is a medical device that received FDA 510(k) clearance on 1989-08-22. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K893837.

When did CVIS ULTRA-SCAN ONE IMAGING CATHETER receive FDA 510(k) clearance?

CVIS ULTRA-SCAN ONE IMAGING CATHETER received FDA 510(k) clearance on 1989-08-22, under 510(k) number K893837.

Who is the listed applicant for CVIS ULTRA-SCAN ONE IMAGING CATHETER?

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

What is the FDA product code for CVIS ULTRA-SCAN ONE IMAGING CATHETER?

The FDA product code for CVIS ULTRA-SCAN ONE IMAGING CATHETER is IYO.

Related Clinical Trials

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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Other records listing Cardiovascular Imaging Systems, 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.

K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/K942231MICROVIEW II/MICRORAIL II CATHETERSK933517AUTOMATIC PULL BACK DEVICEK930232CVIS INSIGHT IMAGING GUIDE CATHETERK924922CVIS INSIGHT IMAGING CATHETERK930311CVIS LONGVIEW

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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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