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FDA 510(k)

DIDECO-SHILEY FLUID COLLECTION BAG

K-Number: K881692 · 1988-07-08

ApplicantShiley, Inc.
Decision Date1988-07-08
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIDECO-SHILEY FLUID COLLECTION BAG is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1988-07-08 under 510(k) number K881692. 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 DIDECO-SHILEY FLUID COLLECTION BAG?

DIDECO-SHILEY FLUID COLLECTION BAG is a medical device that received FDA 510(k) clearance on 1988-07-08. The listed applicant is Shiley, Inc.. The 510(k) number is K881692.

When did DIDECO-SHILEY FLUID COLLECTION BAG receive FDA 510(k) clearance?

DIDECO-SHILEY FLUID COLLECTION BAG received FDA 510(k) clearance on 1988-07-08, under 510(k) number K881692.

Who is the listed applicant for DIDECO-SHILEY FLUID COLLECTION BAG?

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 DIDECO-SHILEY FLUID COLLECTION BAG?

The FDA product code for DIDECO-SHILEY FLUID COLLECTION BAG 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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