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FDA 510(k)

RMI CAROTID BY-PASS SHUNT

K-Number: K860988 · 1986-05-21

ApplicantResearch Medical, Inc.
Decision Date1986-05-21
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RMI CAROTID BY-PASS SHUNT is the device name listed in this FDA 510(k) record. The listed applicant is Research Medical, Inc.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K860988. 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 RMI CAROTID BY-PASS SHUNT?

RMI CAROTID BY-PASS SHUNT is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Research Medical, Inc.. The 510(k) number is K860988.

When did RMI CAROTID BY-PASS SHUNT receive FDA 510(k) clearance?

RMI CAROTID BY-PASS SHUNT received FDA 510(k) clearance on 1986-05-21, under 510(k) number K860988.

Who is the listed applicant for RMI CAROTID BY-PASS SHUNT?

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

What is the FDA product code for RMI CAROTID BY-PASS SHUNT?

The FDA product code for RMI CAROTID BY-PASS SHUNT is DWF.

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Other records listing Research Medical, Inc. as applicant

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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

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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