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)

INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR

K-Number: K931278 · 1993-07-23

ApplicantInterventional Therapeutics Corp.
Decision Date1993-07-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Interventional Therapeutics Corp.. It received FDA 510(k) clearance on 1993-07-23 under 510(k) number K931278. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR?

INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR is a medical device that received FDA 510(k) clearance on 1993-07-23. The listed applicant is Interventional Therapeutics Corp.. The 510(k) number is K931278.

When did INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR receive FDA 510(k) clearance?

INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR received FDA 510(k) clearance on 1993-07-23, under 510(k) number K931278.

Who is the listed applicant for INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR?

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

What is the FDA product code for INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR?

The FDA product code for INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR is GCJ.

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 Interventional Therapeutics 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.

K960832OCCLUSION BALLOON CATHETERK950398CATHETER, BALLOON TYPEK945588DISPOSABLE 1CC SYRINGE WITH LUER LOCKK944354CONTOUR EMBOLIK930456INTHERM SINGLE-STICK RADIALLY EXPANDING DILATORK914866ITC CONTOUR EMBOLI, MODIFICATION

View all 28 devices →

Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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.

↑