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)

MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS

K-Number: K892450 · 1989-10-11

ApplicantQuinton, Inc.
Decision Date1989-10-11
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1989-10-11 under 510(k) number K892450. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS?

MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS is a medical device that received FDA 510(k) clearance on 1989-10-11. The listed applicant is Quinton, Inc.. The 510(k) number is K892450.

When did MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS receive FDA 510(k) clearance?

MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS received FDA 510(k) clearance on 1989-10-11, under 510(k) number K892450.

Who is the listed applicant for MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS?

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 MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS?

The FDA product code for MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS is KGX.

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: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer 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.

↑