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FDA 510(k)

BALLOON RETENTION CHEST CATHETER

K-Number: K802025 · 1980-09-26

ApplicantLoseff Medical Designers, Ltd.
Decision Date1980-09-26
Product CodeGBA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BALLOON RETENTION CHEST CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Loseff Medical Designers, Ltd.. It received FDA 510(k) clearance on 1980-09-26 under 510(k) number K802025. The device is classified under product code GBA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALLOON RETENTION CHEST CATHETER?

BALLOON RETENTION CHEST CATHETER is a medical device that received FDA 510(k) clearance on 1980-09-26. The listed applicant is Loseff Medical Designers, Ltd.. The 510(k) number is K802025.

When did BALLOON RETENTION CHEST CATHETER receive FDA 510(k) clearance?

BALLOON RETENTION CHEST CATHETER received FDA 510(k) clearance on 1980-09-26, under 510(k) number K802025.

Who is the listed applicant for BALLOON RETENTION CHEST CATHETER?

The FDA 510(k) record lists Loseff Medical Designers, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BALLOON RETENTION CHEST CATHETER?

The FDA product code for BALLOON RETENTION CHEST CATHETER is GBA.

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 Loseff Medical Designers, Ltd. 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.

K801349LOSEFF BALLOON TYPE SELF-RETENTION WOUND

Related Devices (Code: GBA)

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.

K861877BYRON WORD BARTHOLIAN GLAND CATHETERByron MedicalK790444ELECATH MULTI-PURPOSE ARTERIAL SURGERElectro-Catheter Corp.K781772CATHETER, TRANSLUMINAL BALLOONMedi-Tech, Inc.K781665TUBE, LEATHERMAN/IMBRUCENational Catheter Co. Div. Mallinckrodt

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.

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