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FDA 510(k)

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES

K-Number: K853101 · 1986-02-24

ApplicantCobe Laboratories, Inc.
Decision Date1986-02-24
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1986-02-24 under 510(k) number K853101. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES?

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES is a medical device that received FDA 510(k) clearance on 1986-02-24. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K853101.

When did VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES receive FDA 510(k) clearance?

VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES received FDA 510(k) clearance on 1986-02-24, under 510(k) number K853101.

Who is the listed applicant for VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES?

The FDA 510(k) record lists Cobe Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES?

The FDA product code for VASCUTER EXTERNAL REINFORCE TRIAXIAL PROSTHESES is DSY.

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Related Devices (Code: DSY)

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

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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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