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FDA 510(k)

TRANSPARENT FILM I.V. SITE/WOUND DRESSING

K-Number: K896421 · 1990-01-31

ApplicantCatalina Biomedical Corp.
Decision Date1990-01-31
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TRANSPARENT FILM I.V. SITE/WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Catalina Biomedical Corp.. It received FDA 510(k) clearance on 1990-01-31 under 510(k) number K896421. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSPARENT FILM I.V. SITE/WOUND DRESSING?

TRANSPARENT FILM I.V. SITE/WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1990-01-31. The listed applicant is Catalina Biomedical Corp.. The 510(k) number is K896421.

When did TRANSPARENT FILM I.V. SITE/WOUND DRESSING receive FDA 510(k) clearance?

TRANSPARENT FILM I.V. SITE/WOUND DRESSING received FDA 510(k) clearance on 1990-01-31, under 510(k) number K896421.

Who is the listed applicant for TRANSPARENT FILM I.V. SITE/WOUND DRESSING?

The FDA 510(k) record lists Catalina Biomedical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANSPARENT FILM I.V. SITE/WOUND DRESSING?

The FDA product code for TRANSPARENT FILM I.V. SITE/WOUND DRESSING is KMK.

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 Catalina Biomedical Corp. 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.

K920050BIOLEX WOUND GEL,K913480WOUND CARE TRAY AK913479WOUND CARE TRAY BK896358VARI/MOIST WOUND DRESSING

Related Devices (Code: KMK)

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.

K180994SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8FInterrad Medical, Inc.K981860A P HARNESSParaworks Enterprise, Ltd.K963365MULTI-PURPOSE MEDICAL TUBE HOLDERByrd Medical Devices, Inc.K941098SECURE-SITEOp-Co Medical Products , Ltd.K943147STATLOCK CVVenetec, Inc.K943047IV START KITSSterile Concepts, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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