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FDA 510(k)

PEDIATRIC DRAIN BAG

K-Number: K896581 · 1990-01-31

ApplicantLaytech Medical Co.
Decision Date1990-01-31
Product CodeFFH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC DRAIN BAG is the device name listed in this FDA 510(k) record. The listed applicant is Laytech Medical Co.. It received FDA 510(k) clearance on 1990-01-31 under 510(k) number K896581. The device is classified under product code FFH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC DRAIN BAG?

PEDIATRIC DRAIN BAG is a medical device that received FDA 510(k) clearance on 1990-01-31. The listed applicant is Laytech Medical Co.. The 510(k) number is K896581.

When did PEDIATRIC DRAIN BAG receive FDA 510(k) clearance?

PEDIATRIC DRAIN BAG received FDA 510(k) clearance on 1990-01-31, under 510(k) number K896581.

Who is the listed applicant for PEDIATRIC DRAIN BAG?

The FDA 510(k) record lists Laytech Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC DRAIN BAG?

The FDA product code for PEDIATRIC DRAIN BAG is FFH.

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 Laytech Medical Co. 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.

K893827PEAK FLOW RATE METER

Related Devices (Code: FFH)

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.

K905016PEDIATRIC AND INFANT CATH KITSDavol, Inc.K871789INTECARE PEDIATRIC URINE COLLECTORMercury Enterprises, 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.

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