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FDA 510(k)

PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F

K-Number: K053491 · 2006-04-27

ApplicantPenumbra, Inc.
Decision Date2006-04-27
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2006-04-27 under 510(k) number K053491. 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 PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F?

PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Penumbra, Inc.. The 510(k) number is K053491.

When did PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F receive FDA 510(k) clearance?

PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F received FDA 510(k) clearance on 2006-04-27, under 510(k) number K053491.

Who is the listed applicant for PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F?

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

What is the FDA product code for PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F?

The FDA product code for PENUMBRA BALLOON GUIDE CATHETER, MODEL 7.5F is DQY.

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Related Devices (Code: 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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