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FDA 510(k)

SCD EXPRESS PORTABLE COMPRESSION SYSTEM

K-Number: K040511 · 2004-06-28

ApplicantTyco Healthcare/Kendall
Decision Date2004-06-28
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCD EXPRESS PORTABLE COMPRESSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tyco Healthcare/Kendall. It received FDA 510(k) clearance on 2004-06-28 under 510(k) number K040511. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCD EXPRESS PORTABLE COMPRESSION SYSTEM?

SCD EXPRESS PORTABLE COMPRESSION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-28. The listed applicant is Tyco Healthcare/Kendall. The 510(k) number is K040511.

When did SCD EXPRESS PORTABLE COMPRESSION SYSTEM receive FDA 510(k) clearance?

SCD EXPRESS PORTABLE COMPRESSION SYSTEM received FDA 510(k) clearance on 2004-06-28, under 510(k) number K040511.

Who is the listed applicant for SCD EXPRESS PORTABLE COMPRESSION SYSTEM?

The FDA 510(k) record lists Tyco Healthcare/Kendall as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCD EXPRESS PORTABLE COMPRESSION SYSTEM?

The FDA product code for SCD EXPRESS PORTABLE COMPRESSION SYSTEM is JOW.

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.

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Other records listing Tyco Healthcare/Kendall 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.

K060339KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERYK051805KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGEK040196KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS

Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , 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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