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FDA 510(k)

CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT

K-Number: K962746 · 1996-10-11

ApplicantCordis Corp.
Decision Date1996-10-11
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1996-10-11 under 510(k) number K962746. 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 AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT?

CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT is a medical device that received FDA 510(k) clearance on 1996-10-11. The listed applicant is Cordis Corp.. The 510(k) number is K962746.

When did CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT receive FDA 510(k) clearance?

CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT received FDA 510(k) clearance on 1996-10-11, under 510(k) number K962746.

Who is the listed applicant for CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT?

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 AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT?

The FDA product code for CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT is DYB.

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.

Other records listing Cordis Corp. 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.

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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.

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.

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