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, SILICONE COATED

K-Number: K772218 · 1977-12-13

ApplicantConcord Laboratories, Inc.
Decision Date1977-12-13
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER, SILICONE COATED is the device name listed in this FDA 510(k) record. The listed applicant is Concord Laboratories, Inc.. It received FDA 510(k) clearance on 1977-12-13 under 510(k) number K772218. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, SILICONE COATED?

CATHETER, SILICONE COATED is a medical device that received FDA 510(k) clearance on 1977-12-13. The listed applicant is Concord Laboratories, Inc.. The 510(k) number is K772218.

When did CATHETER, SILICONE COATED receive FDA 510(k) clearance?

CATHETER, SILICONE COATED received FDA 510(k) clearance on 1977-12-13, under 510(k) number K772218.

Who is the listed applicant for CATHETER, SILICONE COATED?

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

What is the FDA product code for CATHETER, SILICONE COATED?

The FDA product code for CATHETER, SILICONE COATED is EZL.

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 Concord Laboratories, 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.

K883840DRI-VENT ARTERIAL BLOOD SAMPLING KITK871825MECONIUM SUCTION CATHETERK864535TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110K862039CONCORD CARE TRAYK854601SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATHK854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLES

View all 42 devices →

Related Devices (Code: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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.

↑