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FDA 510(k)

PHERESIS NEEDLE ASSEMBLY

K-Number: K810076 · 1981-03-05

ApplicantHaemonetics Corp.
Decision Date1981-03-05
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PHERESIS NEEDLE ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Haemonetics Corp.. It received FDA 510(k) clearance on 1981-03-05 under 510(k) number K810076. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHERESIS NEEDLE ASSEMBLY?

PHERESIS NEEDLE ASSEMBLY is a medical device that received FDA 510(k) clearance on 1981-03-05. The listed applicant is Haemonetics Corp.. The 510(k) number is K810076.

When did PHERESIS NEEDLE ASSEMBLY receive FDA 510(k) clearance?

PHERESIS NEEDLE ASSEMBLY received FDA 510(k) clearance on 1981-03-05, under 510(k) number K810076.

Who is the listed applicant for PHERESIS NEEDLE ASSEMBLY?

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 PHERESIS NEEDLE ASSEMBLY?

The FDA product code for PHERESIS NEEDLE ASSEMBLY is GAA.

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Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, 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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