FDA 510(k)

CBIS CATHETER PULL-BACK DEVICE

K-Number: K921879 · 1992-07-16

ApplicantCardiovascular Imaging Systems, Inc.

Decision Date1992-07-16

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CBIS CATHETER PULL-BACK DEVICE 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 1992-07-16 under 510(k) number K921879. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CBIS CATHETER PULL-BACK DEVICE?

CBIS CATHETER PULL-BACK DEVICE is a medical device that received FDA 510(k) clearance on 1992-07-16. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K921879.

When did CBIS CATHETER PULL-BACK DEVICE receive FDA 510(k) clearance?

CBIS CATHETER PULL-BACK DEVICE received FDA 510(k) clearance on 1992-07-16, under 510(k) number K921879.

Who is the listed applicant for CBIS CATHETER PULL-BACK DEVICE?

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 CBIS CATHETER PULL-BACK DEVICE?

The FDA product code for CBIS CATHETER PULL-BACK DEVICE is DQO.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.