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FDA 510(k)

Benchmark BMX96 Access System

K-Number: K201271 · 2020-06-11

ApplicantPenumbra, Inc.
Decision Date2020-06-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Benchmark BMX96 Access System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2020-06-11 under approval number K201271. 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 Benchmark BMX96 Access System?

Benchmark BMX96 Access System is a medical device that received FDA 510(k) clearance on 2020-06-11. It is manufactured by Penumbra, Inc.. The 510(k) number is K201271.

When was Benchmark BMX96 Access System approved by the FDA?

Benchmark BMX96 Access System received FDA 510(k) clearance on 2020-06-11, under approval number K201271.

What company makes Benchmark BMX96 Access System?

Benchmark BMX96 Access System is manufactured by Penumbra, Inc..

What is the FDA product code for Benchmark BMX96 Access System?

The FDA product code for Benchmark BMX96 Access System is DQY.

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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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