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FDA 510(k)

HERO VASCULAR ACCESS DEVICE

K-Number: K071778 · 2008-01-30

ApplicantGraftcath, Inc.
Decision Date2008-01-30
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HERO VASCULAR ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Graftcath, Inc.. It received FDA 510(k) clearance on 2008-01-30 under 510(k) number K071778. 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 HERO VASCULAR ACCESS DEVICE?

HERO VASCULAR ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2008-01-30. The listed applicant is Graftcath, Inc.. The 510(k) number is K071778.

When did HERO VASCULAR ACCESS DEVICE receive FDA 510(k) clearance?

HERO VASCULAR ACCESS DEVICE received FDA 510(k) clearance on 2008-01-30, under 510(k) number K071778.

Who is the listed applicant for HERO VASCULAR ACCESS DEVICE?

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

What is the FDA product code for HERO VASCULAR ACCESS DEVICE?

The FDA product code for HERO VASCULAR ACCESS DEVICE is DSY.

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Related Devices (Code: DSY)

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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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