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FDA 510(k)

EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL

K-Number: K113101 · 2012-01-17

ApplicantBoston Scientific Corporation
Decision Date2012-01-17
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2012-01-17 under 510(k) number K113101. 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 EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL?

EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL is a medical device that received FDA 510(k) clearance on 2012-01-17. The listed applicant is Boston Scientific Corporation. The 510(k) number is K113101.

When did EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL receive FDA 510(k) clearance?

EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL received FDA 510(k) clearance on 2012-01-17, under 510(k) number K113101.

Who is the listed applicant for EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL?

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

What is the FDA product code for EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL?

The FDA product code for EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL is DSY.

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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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