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)

URESIL VALVE CUTTER

K-Number: K905528 · 1991-04-18

ApplicantUresil Corp.
Decision Date1991-04-18
Product CodeDWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

URESIL VALVE CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Uresil Corp.. It received FDA 510(k) clearance on 1991-04-18 under 510(k) number K905528. The device is classified under product code DWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URESIL VALVE CUTTER?

URESIL VALVE CUTTER is a medical device that received FDA 510(k) clearance on 1991-04-18. The listed applicant is Uresil Corp.. The 510(k) number is K905528.

When did URESIL VALVE CUTTER receive FDA 510(k) clearance?

URESIL VALVE CUTTER received FDA 510(k) clearance on 1991-04-18, under 510(k) number K905528.

Who is the listed applicant for URESIL VALVE CUTTER?

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

What is the FDA product code for URESIL VALVE CUTTER?

The FDA product code for URESIL VALVE CUTTER is DWQ.

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 Uresil Corp. 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.

K003753GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHEK980278URESIL VASCU-FLO INFUSION CATHETERK981344URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATINGK980282URESIL DILATOR WITH RADIOPAQUE MARKERK980889URESIL NEPHRO-URETERAL STENTK972582URESIL GUIDEWIRE

View all 45 devices →

Related Devices (Code: DWQ)

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.

K212894PhasTIPPLeMaitre Vascular, Inc.K041453SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023Smith & Nephew, Inc.K032387TRIVEX SYSTEMSmith & Nephew, Inc.K904507PILLING BRUSH VALVULOTOMEPilling Co.K885046INSITUCAT VALVE STRIPPERAesculap Instruments Corp.K872157HALL VEIN STRIPPERSolco Basle, Inc.

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.

↑