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FDA 510(k)

PICA CATHETER

K-Number: K093970 · 2010-01-15

ApplicantPenumbra, Inc.
Decision Date2010-01-15
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PICA CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2010-01-15 under 510(k) number K093970. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICA CATHETER?

PICA CATHETER is a medical device that received FDA 510(k) clearance on 2010-01-15. The listed applicant is Penumbra, Inc.. The 510(k) number is K093970.

When did PICA CATHETER receive FDA 510(k) clearance?

PICA CATHETER received FDA 510(k) clearance on 2010-01-15, under 510(k) number K093970.

Who is the listed applicant for PICA CATHETER?

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 PICA CATHETER?

The FDA product code for PICA CATHETER is LIT.

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Other records listing Penumbra, Inc. as applicant

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Related Devices (Code: LIT)

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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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