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FDA 510(k)

CATHETER, EMBOLECTOMY, UMI

K-Number: K770569 · 1977-04-05

ApplicantUniversal Medical Instrument Corp.
Decision Date1977-04-05
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, EMBOLECTOMY, UMI is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770569. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, EMBOLECTOMY, UMI?

CATHETER, EMBOLECTOMY, UMI is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K770569.

When did CATHETER, EMBOLECTOMY, UMI receive FDA 510(k) clearance?

CATHETER, EMBOLECTOMY, UMI received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770569.

Who is the listed applicant for CATHETER, EMBOLECTOMY, UMI?

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

What is the FDA product code for CATHETER, EMBOLECTOMY, UMI?

The FDA product code for CATHETER, EMBOLECTOMY, UMI is DXE.

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Other records listing Universal Medical Instrument Corp. as applicant

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Related Devices (Code: DXE)

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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