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 MANTA CATHETER FIXATION DISK

K-Number: K981229 · 1998-04-22

ApplicantMedical Device Technologies, Inc.
Decision Date1998-04-22
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANAN MANTA CATHETER FIXATION DISK is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1998-04-22 under 510(k) number K981229. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN MANTA CATHETER FIXATION DISK?

MANAN MANTA CATHETER FIXATION DISK is a medical device that received FDA 510(k) clearance on 1998-04-22. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K981229.

When did MANAN MANTA CATHETER FIXATION DISK receive FDA 510(k) clearance?

MANAN MANTA CATHETER FIXATION DISK received FDA 510(k) clearance on 1998-04-22, under 510(k) number K981229.

Who is the listed applicant for MANAN MANTA CATHETER FIXATION DISK?

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

What is the FDA product code for MANAN MANTA CATHETER FIXATION DISK?

The FDA product code for MANAN MANTA CATHETER FIXATION DISK is KNY.

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 Medical Device Technologies, 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.

K101832BIOPINCE ULTRA FULL CORE BIOPSY INSTRUMENTK053518INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK051421INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHORK050873CANALIZER HYDROPHILIC GUIDE WIREK043523INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLEK042464V-CORE FULL CORE BREAST BIOPSY INSTRUMENT

View all 46 devices →

Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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.

↑