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)

MANAN GENERAL UTILITY DRAINAGE CATHETER

K-Number: K953713 · 1996-03-26

ApplicantManan Medical Products, Inc.
Decision Date1996-03-26
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

MANAN GENERAL UTILITY DRAINAGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Manan Medical Products, Inc.. It received FDA 510(k) clearance on 1996-03-26 under 510(k) number K953713. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN GENERAL UTILITY DRAINAGE CATHETER?

MANAN GENERAL UTILITY DRAINAGE CATHETER is a medical device that received FDA 510(k) clearance on 1996-03-26. The listed applicant is Manan Medical Products, Inc.. The 510(k) number is K953713.

When did MANAN GENERAL UTILITY DRAINAGE CATHETER receive FDA 510(k) clearance?

MANAN GENERAL UTILITY DRAINAGE CATHETER received FDA 510(k) clearance on 1996-03-26, under 510(k) number K953713.

Who is the listed applicant for MANAN GENERAL UTILITY DRAINAGE CATHETER?

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

What is the FDA product code for MANAN GENERAL UTILITY DRAINAGE CATHETER?

The FDA product code for MANAN GENERAL UTILITY DRAINAGE CATHETER is LJE.

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 Manan Medical Products, 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.

K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLEK011209MANAN SPRITACRE SPINAL NEEDLESK983620MANAN SPINAL NEEDLESK980536EPIDURAL NEEDLEK981386MANAN BLUNT NEEDLEK980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

View all 39 devices →

Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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.

↑