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FDA 510(k)

PLASMA PRODUCTS CO., INTRA/ADMIN/SET-

K-Number: K800637 · 1980-05-08

ApplicantPlasma Products Co.
Decision Date1980-05-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLASMA PRODUCTS CO., INTRA/ADMIN/SET- is the device name listed in this FDA 510(k) record. The listed applicant is Plasma Products Co.. It received FDA 510(k) clearance on 1980-05-08 under 510(k) number K800637. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMA PRODUCTS CO., INTRA/ADMIN/SET-?

PLASMA PRODUCTS CO., INTRA/ADMIN/SET- is a medical device that received FDA 510(k) clearance on 1980-05-08. The listed applicant is Plasma Products Co.. The 510(k) number is K800637.

When did PLASMA PRODUCTS CO., INTRA/ADMIN/SET- receive FDA 510(k) clearance?

PLASMA PRODUCTS CO., INTRA/ADMIN/SET- received FDA 510(k) clearance on 1980-05-08, under 510(k) number K800637.

Who is the listed applicant for PLASMA PRODUCTS CO., INTRA/ADMIN/SET-?

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

What is the FDA product code for PLASMA PRODUCTS CO., INTRA/ADMIN/SET-?

The FDA product code for PLASMA PRODUCTS CO., INTRA/ADMIN/SET- is FPA.

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 Plasma Products 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.

K800638PLASMA PRODUCTS CO. NON-VENTED INTRA/SET

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

Official Source

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