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FDA 510(k)

STATFLO

K-Number: K880180 · 1988-03-22

ApplicantImodex, Inc.
Decision Date1988-03-22
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STATFLO is the device name listed in this FDA 510(k) record. The listed applicant is Imodex, Inc.. It received FDA 510(k) clearance on 1988-03-22 under 510(k) number K880180. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATFLO?

STATFLO is a medical device that received FDA 510(k) clearance on 1988-03-22. The listed applicant is Imodex, Inc.. The 510(k) number is K880180.

When did STATFLO receive FDA 510(k) clearance?

STATFLO received FDA 510(k) clearance on 1988-03-22, under 510(k) number K880180.

Who is the listed applicant for STATFLO?

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

What is the FDA product code for STATFLO?

The FDA product code for STATFLO is DWF.

Related Clinical Trials

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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Other records listing Imodex, Inc. as applicant

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.

K860497CAROTID BALLOON SHUNT

Related Devices (Code: DWF)

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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