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FDA 510(k)

SINGLE LUMEN SUBCLAVIAN CANNULA

K-Number: K840197 · 1984-04-25

ApplicantShiley, Inc.
Decision Date1984-04-25
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE LUMEN SUBCLAVIAN CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1984-04-25 under 510(k) number K840197. The device is classified under product code LFJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE LUMEN SUBCLAVIAN CANNULA?

SINGLE LUMEN SUBCLAVIAN CANNULA is a medical device that received FDA 510(k) clearance on 1984-04-25. The listed applicant is Shiley, Inc.. The 510(k) number is K840197.

When did SINGLE LUMEN SUBCLAVIAN CANNULA receive FDA 510(k) clearance?

SINGLE LUMEN SUBCLAVIAN CANNULA received FDA 510(k) clearance on 1984-04-25, under 510(k) number K840197.

Who is the listed applicant for SINGLE LUMEN SUBCLAVIAN CANNULA?

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 SINGLE LUMEN SUBCLAVIAN CANNULA?

The FDA product code for SINGLE LUMEN SUBCLAVIAN CANNULA is LFJ.

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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: LFJ)

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.

K920780MEDSURG INSERTION TRAYMedsurg Industries, Inc.K925819AKCESS0CATH KITAkcess Medical Products, Inc.K925818AKCESS-CATHAkcess Medical Products, Inc.K913468ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAYCook, Inc.K931120COAXIAL ACUTE CATHETERAkcess Medical Products, Inc.K920634SPLITTABLE SHEATH INTRODUCER SETAkcess Medical Products, 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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