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FDA 510(k)

HAEMONETICS 1400 ML THERAPEUTIC BAG

K-Number: K810313 · 1981-03-31

ApplicantHaemonetics Corp.
Decision Date1981-03-31
Product CodeKSR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HAEMONETICS 1400 ML THERAPEUTIC BAG is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810313. 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 HAEMONETICS 1400 ML THERAPEUTIC BAG?

HAEMONETICS 1400 ML THERAPEUTIC BAG is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Haemonetics Corp.. The 510(k) number is K810313.

When did HAEMONETICS 1400 ML THERAPEUTIC BAG receive FDA 510(k) clearance?

HAEMONETICS 1400 ML THERAPEUTIC BAG received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810313.

Who is the listed applicant for HAEMONETICS 1400 ML THERAPEUTIC BAG?

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

What is the FDA product code for HAEMONETICS 1400 ML THERAPEUTIC BAG?

The FDA product code for HAEMONETICS 1400 ML THERAPEUTIC BAG is KSR.

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Other records listing Haemonetics 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.

K122262ORTHOPAT ADVANCE PERIOPERATIVE AUTOTRANSFUSION SYSTEMK120586CELL SAVER ELITEK101907HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEMK062801SMARTSUCTION SOLO DEVICEK061103HAEMONETICS 40U RBC FILTER BAGK053000HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT)

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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, UMBILICUPDeroyalK810500BLOOD FREEZING BAGDelmed, Inc.K810897ALPHA PLASTIC PLASMA BOTTLEAlpha Therapeutic Corp.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.

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