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FDA 510(k)

FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER

K-Number: K895506 · 1990-02-09

ApplicantVas-Cath, Inc.
Decision Date1990-02-09
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER 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 1990-02-09 under 510(k) number K895506. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER?

FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is Vas-Cath, Inc.. The 510(k) number is K895506.

When did FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER receive FDA 510(k) clearance?

FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER received FDA 510(k) clearance on 1990-02-09, under 510(k) number K895506.

Who is the listed applicant for FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER?

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 FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER?

The FDA product code for FLEXXICON PLUS DUAL LUMEN DIALYSIS CATHETER is LFJ.

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: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess 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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