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FDA 510(k)

INFUSION ACCELERATOR

K-Number: K771458 · 1977-08-26

ApplicantTerumo America, Inc.
Decision Date1977-08-26
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUSION ACCELERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Terumo America, Inc.. It received FDA 510(k) clearance on 1977-08-26 under 510(k) number K771458. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUSION ACCELERATOR?

INFUSION ACCELERATOR is a medical device that received FDA 510(k) clearance on 1977-08-26. The listed applicant is Terumo America, Inc.. The 510(k) number is K771458.

When did INFUSION ACCELERATOR receive FDA 510(k) clearance?

INFUSION ACCELERATOR received FDA 510(k) clearance on 1977-08-26, under 510(k) number K771458.

Who is the listed applicant for INFUSION ACCELERATOR?

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

What is the FDA product code for INFUSION ACCELERATOR?

The FDA product code for INFUSION ACCELERATOR is KZD.

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Other records listing Terumo America, 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.

K811523PLASMA FLEXK802970TERUMO HOLLOW FIBER OXYGENATORK802441CLIRANS TH10 HOLLOW FIBER DIALYZERK802122CLIRANS TH13 HOLLOW FIBER DIALYZERK801194CLIRANS TE07 HOLLOW FIBER DIALYZERK801193CLIRANS TE15 HOLLOW FIBER DIALYZER

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Related Devices (Code: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K930012KAWASUMI LABORATORIES K-CUFFKawasumi Laboratories Co., Ltd.

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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