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FDA 510(k)

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL

K-Number: K913801 · 1991-10-16

ApplicantCordis Corp.
Decision Date1991-10-16
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1991-10-16 under 510(k) number K913801. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL?

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL is a medical device that received FDA 510(k) clearance on 1991-10-16. The listed applicant is Cordis Corp.. The 510(k) number is K913801.

When did CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL receive FDA 510(k) clearance?

CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL received FDA 510(k) clearance on 1991-10-16, under 510(k) number K913801.

Who is the listed applicant for CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL?

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

What is the FDA product code for CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL?

The FDA product code for CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL is DYB.

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Related Devices (Code: DYB)

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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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