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FDA 510(k)

CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE

K-Number: K911794 · 1991-07-19

ApplicantCordis Corp.
Decision Date1991-07-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1991-07-19 under 510(k) number K911794. 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 CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE?

CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Cordis Corp.. The 510(k) number is K911794.

When did CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE receive FDA 510(k) clearance?

CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE received FDA 510(k) clearance on 1991-07-19, under 510(k) number K911794.

Who is the listed applicant for CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE?

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 CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE?

The FDA product code for CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE is DYB.

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Other records listing Cordis Corp. as applicant

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Related Devices (Code: DYB)

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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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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