FDA 510(k)

EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN

K-Number: K052964 · 2006-01-06

Decision Date2006-01-06

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2006-01-06 under 510(k) number K052964. 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 AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN?

EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN is a medical device that received FDA 510(k) clearance on 2006-01-06. The listed applicant is Boston Scientific Corp. The 510(k) number is K052964.

When did EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN receive FDA 510(k) clearance?

EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN received FDA 510(k) clearance on 2006-01-06, under 510(k) number K052964.

Who is the listed applicant for EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN?

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

What is the FDA product code for EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN?

The FDA product code for EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN 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.