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FDA 510(k)

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL

K-Number: K921631 · 1992-07-02

ApplicantCardiovascular Imaging Systems, Inc.
Decision Date1992-07-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL 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 1992-07-02 under 510(k) number K921631. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL?

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K921631.

When did CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL receive FDA 510(k) clearance?

CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL received FDA 510(k) clearance on 1992-07-02, under 510(k) number K921631.

Who is the listed applicant for CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL?

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 INSIGHT IMAGING CATHETER FOR INTRALUMINAL?

The FDA product code for CVIS INSIGHT IMAGING CATHETER FOR INTRALUMINAL is ITX.

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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: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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