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)

CATHETER WITH INTRODUCER AND SYRINGES

K-Number: K915129 · 1992-04-08

ApplicantUtah Pioneer Medical, Inc.
Decision Date1992-04-08
Product CodeGCA
Advisory CommitteeGU
DecisionUnknown

Device Summary

CATHETER WITH INTRODUCER AND SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Utah Pioneer Medical, Inc.. It received FDA 510(k) clearance on 1992-04-08 under 510(k) number K915129. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CATHETER WITH INTRODUCER AND SYRINGES?

CATHETER WITH INTRODUCER AND SYRINGES is a medical device that received FDA 510(k) clearance on 1992-04-08. The listed applicant is Utah Pioneer Medical, Inc.. The 510(k) number is K915129.

When did CATHETER WITH INTRODUCER AND SYRINGES receive FDA 510(k) clearance?

CATHETER WITH INTRODUCER AND SYRINGES received FDA 510(k) clearance on 1992-04-08, under 510(k) number K915129.

Who is the listed applicant for CATHETER WITH INTRODUCER AND SYRINGES?

The FDA 510(k) record lists Utah Pioneer Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER WITH INTRODUCER AND SYRINGES?

The FDA product code for CATHETER WITH INTRODUCER AND SYRINGES is GCA.

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 Utah Pioneer Medical, 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.

K933353IRRIGATION AND ASPIRATION DEVICE FOR LAPAROSCOPIC AND OPEN SURGICAL PROCEDURES

Related Devices (Code: GCA)

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.

K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd.K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific CorporationK210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd.K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, 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.

↑