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FDA 510(k)

S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM

K-Number: K031554 · 2003-07-25

ApplicantGenzyme Biosurgery
Decision Date2003-07-25
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Biosurgery. It received FDA 510(k) clearance on 2003-07-25 under 510(k) number K031554. 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 S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM?

S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-07-25. The listed applicant is Genzyme Biosurgery. The 510(k) number is K031554.

When did S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM receive FDA 510(k) clearance?

S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM received FDA 510(k) clearance on 2003-07-25, under 510(k) number K031554.

Who is the listed applicant for S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM?

The FDA 510(k) record lists Genzyme Biosurgery as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM?

The FDA product code for S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM is CAC.

Related Clinical Trials

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Other records listing Genzyme Biosurgery 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.

K030212MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTUREK022989RADLITE TISSUE RETRACTOR SYSTEMK022410SAPH-LOOP LIGATING LOOP

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

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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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