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FDA 510(k)

PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C

K-Number: K082923 · 2008-10-24

ApplicantLife-Tech, Inc.
Decision Date2008-10-24
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech, Inc.. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K082923. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C?

PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Life-Tech, Inc.. The 510(k) number is K082923.

When did PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C receive FDA 510(k) clearance?

PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C received FDA 510(k) clearance on 2008-10-24, under 510(k) number K082923.

Who is the listed applicant for PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C?

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

What is the FDA product code for PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C?

The FDA product code for PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C is CAC.

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Other records listing Life-Tech, 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.

K120234EZONO 3000K111355ECHOBRIGHTK102813EZONO 3000K102007PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,K093662ECHOBRIGHTK093485VESISCAN

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Related Devices (Code: CAC)

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.

K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.K240426Aventus Clot Management SystemInquis MedicalK240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc.K221483FlowSaver Blood Return SystemInari Medical, Inc.K221722Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)Haemonetics Corporation

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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