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FDA 510(k)

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT

K-Number: K021547 · 2003-01-24

ApplicantJotec GmbH
Decision Date2003-01-24
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Jotec GmbH. It received FDA 510(k) clearance on 2003-01-24 under 510(k) number K021547. 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 FLOWLINE BIOPORE EPTFE VASCULAR GRAFT?

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2003-01-24. The listed applicant is Jotec GmbH. The 510(k) number is K021547.

When did FLOWLINE BIOPORE EPTFE VASCULAR GRAFT receive FDA 510(k) clearance?

FLOWLINE BIOPORE EPTFE VASCULAR GRAFT received FDA 510(k) clearance on 2003-01-24, under 510(k) number K021547.

Who is the listed applicant for FLOWLINE BIOPORE EPTFE VASCULAR GRAFT?

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

What is the FDA product code for FLOWLINE BIOPORE EPTFE VASCULAR GRAFT?

The FDA product code for FLOWLINE BIOPORE EPTFE VASCULAR GRAFT 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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