Guidant Vasoview Endoscopic Vessel Harvesting System

by Guidant Corp.

510(k) K030512

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

510(k) K030512↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK030512	Date14 May 2003Cleared	StatusActive

Recalls

1 recall · FDA

- Terminated Z-0614-2011 FDA Unclassified (pre-2012) initiated 5 Feb 2009
Sterility may be compromised by a loss of package integrity.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K030512
FDA Product Code: GCJ

Device Class: Class II
Regulation: 21 CFR Part 876.1500
Advisory Committee: Gastroenterology, Urology
FDA Decision: SESE Substantially Equivalent

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