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)

MAGLINTE ENTEROCLYSIS CATHETER

K-Number: K884379 · 1989-02-28

ApplicantLafayette Pharmacal, Inc.
Decision Date1989-02-28
Product CodeFGD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MAGLINTE ENTEROCLYSIS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Lafayette Pharmacal, Inc.. It received FDA 510(k) clearance on 1989-02-28 under 510(k) number K884379. The device is classified under product code FGD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGLINTE ENTEROCLYSIS CATHETER?

MAGLINTE ENTEROCLYSIS CATHETER is a medical device that received FDA 510(k) clearance on 1989-02-28. The listed applicant is Lafayette Pharmacal, Inc.. The 510(k) number is K884379.

When did MAGLINTE ENTEROCLYSIS CATHETER receive FDA 510(k) clearance?

MAGLINTE ENTEROCLYSIS CATHETER received FDA 510(k) clearance on 1989-02-28, under 510(k) number K884379.

Who is the listed applicant for MAGLINTE ENTEROCLYSIS CATHETER?

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

What is the FDA product code for MAGLINTE ENTEROCLYSIS CATHETER?

The FDA product code for MAGLINTE ENTEROCLYSIS CATHETER is FGD.

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 Lafayette Pharmacal, 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.

K931896PRO-FLO SYSTEMK881609SITZMARKSK860441ENTROKIT WITH MAGLINTE CATHETER

Related Devices (Code: FGD)

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.

K223890NAJA Gastrointestinal CatheterChess Medical, Inc.K905026DUAL FLEX NON-LATEXMmi, Inc.K905574SLIM LINE RETENTION TIP W/ SILICONE RUBBER CUFFE-Z-Em, Inc.K904299SLIM LINE RETENT TIP W/SILICONE INFLATION CUFFE-Z-Em, Inc.K872006DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFFMac Lee Medical Products

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.

↑