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FDA 510(k)

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM

K-Number: K884564 · 1989-05-05

ApplicantShiley, Inc.
Decision Date1989-05-05
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1989-05-05 under 510(k) number K884564. 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 SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM?

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Shiley, Inc.. The 510(k) number is K884564.

When did SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM receive FDA 510(k) clearance?

SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM received FDA 510(k) clearance on 1989-05-05, under 510(k) number K884564.

Who is the listed applicant for SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM?

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

What is the FDA product code for SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM?

The FDA product code for SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM is CAC.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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