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FDA 510(k)

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM

K-Number: K022167 · 2003-03-07

ApplicantPall Corp.
Decision Date2003-03-07
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pall Corp.. It received FDA 510(k) clearance on 2003-03-07 under 510(k) number K022167. 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 PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM?

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM is a medical device that received FDA 510(k) clearance on 2003-03-07. The listed applicant is Pall Corp.. The 510(k) number is K022167.

When did PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM receive FDA 510(k) clearance?

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM received FDA 510(k) clearance on 2003-03-07, under 510(k) number K022167.

Who is the listed applicant for PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM?

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

What is the FDA product code for PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM?

The FDA product code for PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM is CAC.

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Other records listing Pall Corp. 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.

K993379PALL SUPOR AEF FILTERK980762PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE

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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