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FDA 510(k)

CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING

K-Number: K895150 · 1989-11-28

ApplicantShiley, Inc.
Decision Date1989-11-28
Product CodeCCE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1989-11-28 under 510(k) number K895150. The device is classified under product code CCE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING?

CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING is a medical device that received FDA 510(k) clearance on 1989-11-28. The listed applicant is Shiley, Inc.. The 510(k) number is K895150.

When did CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING receive FDA 510(k) clearance?

CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING received FDA 510(k) clearance on 1989-11-28, under 510(k) number K895150.

Who is the listed applicant for CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING?

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 CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING?

The FDA product code for CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING is CCE.

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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: CCE)

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.

K935778VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEMVia Medical Corp.K912145SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIAS & W Medico TeknikK910453TOPS NEEDLE TIP PROBE & PVC TIP PROBEBaxter Healthcare CorpK905397PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEMPuritan Bennett Corp.K896311OPTEX BLOOD GAS MONITORING SYSTEMOptex BiomedicalK890624TISSUE OXYGEN MONITOR SYSTEM, MODEL IIBaxter Healthcare Corp

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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