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FDA 510(k)

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

K-Number: K024097 · 2003-02-14

ApplicantSummit Medical , Ltd.
Decision Date2003-02-14
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medical , Ltd.. It received FDA 510(k) clearance on 2003-02-14 under 510(k) number K024097. 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 SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14?

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 is a medical device that received FDA 510(k) clearance on 2003-02-14. The listed applicant is Summit Medical , Ltd.. The 510(k) number is K024097.

When did SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 receive FDA 510(k) clearance?

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 received FDA 510(k) clearance on 2003-02-14, under 510(k) number K024097.

Who is the listed applicant for SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14?

The FDA 510(k) record lists Summit Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14?

The FDA product code for SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14 is CAC.

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Other records listing Summit Medical , Ltd. 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.

K173110GRAFTSITEK170388ANCHORMAN Tibial Ligament Fixation DeviceK022477SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SETK022489SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514

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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