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FDA 510(k)

MICRODOSE CATH, MODELS 90121-201, -202, -203

K-Number: K011383 · 2001-06-25

ApplicantDurect Corp.
Decision Date2001-06-25
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MICRODOSE CATH, MODELS 90121-201, -202, -203 is the device name listed in this FDA 510(k) record. The listed applicant is Durect Corp.. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K011383. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRODOSE CATH, MODELS 90121-201, -202, -203?

MICRODOSE CATH, MODELS 90121-201, -202, -203 is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Durect Corp.. The 510(k) number is K011383.

When did MICRODOSE CATH, MODELS 90121-201, -202, -203 receive FDA 510(k) clearance?

MICRODOSE CATH, MODELS 90121-201, -202, -203 received FDA 510(k) clearance on 2001-06-25, under 510(k) number K011383.

Who is the listed applicant for MICRODOSE CATH, MODELS 90121-201, -202, -203?

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

What is the FDA product code for MICRODOSE CATH, MODELS 90121-201, -202, -203?

The FDA product code for MICRODOSE CATH, MODELS 90121-201, -202, -203 is ETD.

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Related Devices (Code: ETD)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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