Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Rex Medical Aspiration Pump

K-Number: K173389 · 2018-01-30

Decision Date2018-01-30
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rex Medical Aspiration Pump is the device name listed in this FDA 510(k) record. The listed applicant is Rex Medical, L.P.. It received FDA 510(k) clearance on 2018-01-30 under 510(k) number K173389. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rex Medical Aspiration Pump?

Rex Medical Aspiration Pump is a medical device that received FDA 510(k) clearance on 2018-01-30. The listed applicant is Rex Medical, L.P.. The 510(k) number is K173389.

When did Rex Medical Aspiration Pump receive FDA 510(k) clearance?

Rex Medical Aspiration Pump received FDA 510(k) clearance on 2018-01-30, under 510(k) number K173389.

Who is the listed applicant for Rex Medical Aspiration Pump?

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

What is the FDA product code for Rex Medical Aspiration Pump?

The FDA product code for Rex Medical Aspiration Pump is BTA.

Other records listing Rex Medical, L.P. 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.

Related Devices (Code: BTA)

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.

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.