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)

NON-STERILE SHADOW-STRIPE CATHETER

K-Number: K812717 · 1981-10-19

ApplicantQuinton, Inc.
Decision Date1981-10-19
Product CodeFKO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NON-STERILE SHADOW-STRIPE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1981-10-19 under 510(k) number K812717. The device is classified under product code FKO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-STERILE SHADOW-STRIPE CATHETER?

NON-STERILE SHADOW-STRIPE CATHETER is a medical device that received FDA 510(k) clearance on 1981-10-19. The listed applicant is Quinton, Inc.. The 510(k) number is K812717.

When did NON-STERILE SHADOW-STRIPE CATHETER receive FDA 510(k) clearance?

NON-STERILE SHADOW-STRIPE CATHETER received FDA 510(k) clearance on 1981-10-19, under 510(k) number K812717.

Who is the listed applicant for NON-STERILE SHADOW-STRIPE CATHETER?

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

What is the FDA product code for NON-STERILE SHADOW-STRIPE CATHETER?

The FDA product code for NON-STERILE SHADOW-STRIPE CATHETER is FKO.

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 Quinton, 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.

K032038PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601K021906QUINTON Q-CATH, MODEL 000460K003576Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503K001492QUINTON Q-STRESS, MODEL 000483K992908Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)K990866QUINTON MEDTRACK CR PLUS TREADMILL

View all 164 devices →

Related Devices (Code: FKO)

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.

K964514CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSISCorpak, Inc.K974570PERITONEAL DIALYSIS CATHETER CONNECTORMedigroup, Inc.K910787TITANIUM CONNECTOR (2 PART)Accurate Surgical Instruments Co.K885037AMUKIN 50% - AIRSPRAY(R)Bernard J. Cooney, P.A.K874650PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)Quinton, Inc.K872221DIALY-NATE SET & DIALY-NATE CATHETERGesco Intl., 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.

↑