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)

PLASMAPOOLER

K-Number: K801219 · 1980-10-31

ApplicantNorth American Biologicals, Inc.
Decision Date1980-10-31
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLASMAPOOLER is the device name listed in this FDA 510(k) record. The listed applicant is North American Biologicals, Inc.. It received FDA 510(k) clearance on 1980-10-31 under 510(k) number K801219. The device is classified under product code KSR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLASMAPOOLER?

PLASMAPOOLER is a medical device that received FDA 510(k) clearance on 1980-10-31. The listed applicant is North American Biologicals, Inc.. The 510(k) number is K801219.

When did PLASMAPOOLER receive FDA 510(k) clearance?

PLASMAPOOLER received FDA 510(k) clearance on 1980-10-31, under 510(k) number K801219.

Who is the listed applicant for PLASMAPOOLER?

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

What is the FDA product code for PLASMAPOOLER?

The FDA product code for PLASMAPOOLER is KSR.

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 North American Biologicals, 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.

K820301PLASMA POOLER HEAT SEALERK801425RH CONTROLK781896BLOOD GROUP SUBSTANCE A,BK781895BLOOD GROUP SUBSTANCE BK781862BLOOD GROUP SUBSTANCE A

Related Devices (Code: KSR)

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.

K032827KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501Tyco HealthcareK020753DEROYAL SURGICAL, UMBILICUPDeroyalK810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.K810500BLOOD FREEZING BAGDelmed, Inc.K811523PLASMA FLEXTerumo America, Inc.K811449HAEMONETICS 1000ML COMPONENT BAGHaemonetics Corp.

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.

↑