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FDA 510(k)

PHLEBOPUMP, MODEL 1000

K-Number: K003284 · 2001-01-17

Decision Date2001-01-17
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHLEBOPUMP, MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Prevent Products, Inc.. It received FDA 510(k) clearance on 2001-01-17 under 510(k) number K003284. 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 PHLEBOPUMP, MODEL 1000?

PHLEBOPUMP, MODEL 1000 is a medical device that received FDA 510(k) clearance on 2001-01-17. The listed applicant is Prevent Products, Inc.. The 510(k) number is K003284.

When did PHLEBOPUMP, MODEL 1000 receive FDA 510(k) clearance?

PHLEBOPUMP, MODEL 1000 received FDA 510(k) clearance on 2001-01-17, under 510(k) number K003284.

Who is the listed applicant for PHLEBOPUMP, MODEL 1000?

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

What is the FDA product code for PHLEBOPUMP, MODEL 1000?

The FDA product code for PHLEBOPUMP, MODEL 1000 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.

Other records listing Prevent Products, 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.

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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