FDA 510(k)

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)

K-Number: K864146 · 1986-11-05

Decision Date1986-11-05

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Thoracic Systems. It received FDA 510(k) clearance on 1986-11-05 under 510(k) number K864146. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)?

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) is a medical device that received FDA 510(k) clearance on 1986-11-05. The listed applicant is Cardio Thoracic Systems. The 510(k) number is K864146.

When did DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) receive FDA 510(k) clearance?

DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) received FDA 510(k) clearance on 1986-11-05, under 510(k) number K864146.

Who is the listed applicant for DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)?

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

What is the FDA product code for DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE)?

The FDA product code for DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) is GDW.

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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.