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FDA 510(k)

BENELLI ACCESS DEVICE

K-Number: K111334 · 2011-08-01

ApplicantVascular Solutions, Inc.
Decision Date2011-08-01
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BENELLI ACCESS DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2011-08-01 under 510(k) number K111334. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BENELLI ACCESS DEVICE?

BENELLI ACCESS DEVICE is a medical device that received FDA 510(k) clearance on 2011-08-01. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K111334.

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

BENELLI ACCESS DEVICE received FDA 510(k) clearance on 2011-08-01, under 510(k) number K111334.

Who is the listed applicant for BENELLI ACCESS DEVICE?

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

What is the FDA product code for BENELLI ACCESS DEVICE?

The FDA product code for BENELLI ACCESS DEVICE is DQY.

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Other records listing Vascular Solutions, Inc. as applicant

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Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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