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FDA 510(k)

PANAVIA F 2.0

K-Number: K032455 · 2003-11-07

ApplicantKuraray Medical, Inc.
Decision Date2003-11-07
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PANAVIA F 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Medical, Inc.. It received FDA 510(k) clearance on 2003-11-07 under 510(k) number K032455. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANAVIA F 2.0?

PANAVIA F 2.0 is a medical device that received FDA 510(k) clearance on 2003-11-07. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K032455.

When did PANAVIA F 2.0 receive FDA 510(k) clearance?

PANAVIA F 2.0 received FDA 510(k) clearance on 2003-11-07, under 510(k) number K032455.

Who is the listed applicant for PANAVIA F 2.0?

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

What is the FDA product code for PANAVIA F 2.0?

The FDA product code for PANAVIA F 2.0 is EMA.

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Related Devices (Code: EMA)

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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