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FDA 510(k)

MODIFICATION TO PANAVIA 21

K-Number: K012438 · 2001-09-05

ApplicantKuraray Medical, Inc.
Decision Date2001-09-05
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO PANAVIA 21 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 2001-09-05 under 510(k) number K012438. 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 MODIFICATION TO PANAVIA 21?

MODIFICATION TO PANAVIA 21 is a medical device that received FDA 510(k) clearance on 2001-09-05. The listed applicant is Kuraray Medical, Inc.. The 510(k) number is K012438.

When did MODIFICATION TO PANAVIA 21 receive FDA 510(k) clearance?

MODIFICATION TO PANAVIA 21 received FDA 510(k) clearance on 2001-09-05, under 510(k) number K012438.

Who is the listed applicant for MODIFICATION TO PANAVIA 21?

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 MODIFICATION TO PANAVIA 21?

The FDA product code for MODIFICATION TO PANAVIA 21 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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