FDA 510(k)

INJECTOR FILL TUBE

K-Number: K911549 · 1991-07-18

Decision Date1991-07-18

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INJECTOR FILL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is The R Group. It received FDA 510(k) clearance on 1991-07-18 under 510(k) number K911549. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INJECTOR FILL TUBE?

INJECTOR FILL TUBE is a medical device that received FDA 510(k) clearance on 1991-07-18. The listed applicant is The R Group. The 510(k) number is K911549.

When did INJECTOR FILL TUBE receive FDA 510(k) clearance?

INJECTOR FILL TUBE received FDA 510(k) clearance on 1991-07-18, under 510(k) number K911549.

Who is the listed applicant for INJECTOR FILL TUBE?

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

What is the FDA product code for INJECTOR FILL TUBE?

The FDA product code for INJECTOR FILL TUBE is DXT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The R Group as applicant

K905415BRAIDED HIGH PRESSURE CATHETER CONNECTOR K912076POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF K905416VESSEL DILATOR

Related Devices (Code: DXT)

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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.