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FDA 510(k)

PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA

K-Number: K881691 · 1988-07-05

ApplicantShiley, Inc.
Decision Date1988-07-05
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1988-07-05 under 510(k) number K881691. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA?

PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA is a medical device that received FDA 510(k) clearance on 1988-07-05. The listed applicant is Shiley, Inc.. The 510(k) number is K881691.

When did PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA receive FDA 510(k) clearance?

PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA received FDA 510(k) clearance on 1988-07-05, under 510(k) number K881691.

Who is the listed applicant for PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA?

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 PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA?

The FDA product code for PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA is DWF.

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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: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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