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FDA 510(k)

VAS-CATH DUALATOR(TM) VESSEL DILATOR

K-Number: K914210 · 1993-07-01

ApplicantVas-Cath, Inc.
Decision Date1993-07-01
Product CodeFKA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VAS-CATH DUALATOR(TM) VESSEL DILATOR is the device name listed in this FDA 510(k) record. The listed applicant is Vas-Cath, Inc.. It received FDA 510(k) clearance on 1993-07-01 under 510(k) number K914210. The device is classified under product code FKA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VAS-CATH DUALATOR(TM) VESSEL DILATOR?

VAS-CATH DUALATOR(TM) VESSEL DILATOR is a medical device that received FDA 510(k) clearance on 1993-07-01. The listed applicant is Vas-Cath, Inc.. The 510(k) number is K914210.

When did VAS-CATH DUALATOR(TM) VESSEL DILATOR receive FDA 510(k) clearance?

VAS-CATH DUALATOR(TM) VESSEL DILATOR received FDA 510(k) clearance on 1993-07-01, under 510(k) number K914210.

Who is the listed applicant for VAS-CATH DUALATOR(TM) VESSEL DILATOR?

The FDA 510(k) record lists Vas-Cath, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VAS-CATH DUALATOR(TM) VESSEL DILATOR?

The FDA product code for VAS-CATH DUALATOR(TM) VESSEL DILATOR is FKA.

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 Vas-Cath, Inc. 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.

K973013OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETERK965178NIAGARA DUAL LUMEN CATHETERK964881ULTRAVERSE PTA CATHETERK970725OPTI-PLAST XL 5.5 F PTA CATHETERK941706OPTI-PLAST ANGIOPLASTY CATHETERK925485VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER

View all 27 devices →

Related Devices (Code: FKA)

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.

K022620SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRTSpire Biomedical, Inc.K910502VESSEL DILATORSAkcess Medical Products, 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.

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