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FDA 510(k)

VESSEL DILATOR

K-Number: K905416 · 1991-03-25

ApplicantThe R Group
Decision Date1991-03-25
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VESSEL DILATOR 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 1991-03-25 under 510(k) number K905416. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VESSEL DILATOR?

VESSEL DILATOR is a medical device that received FDA 510(k) clearance on 1991-03-25. The listed applicant is The R Group. The 510(k) number is K905416.

When did VESSEL DILATOR receive FDA 510(k) clearance?

VESSEL DILATOR received FDA 510(k) clearance on 1991-03-25, under 510(k) number K905416.

Who is the listed applicant for VESSEL DILATOR?

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 VESSEL DILATOR?

The FDA product code for VESSEL DILATOR is DRE.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The R Group 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.

K905415BRAIDED HIGH PRESSURE CATHETER CONNECTORK912076POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONFK911549INJECTOR FILL TUBE

Related Devices (Code: DRE)

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.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

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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