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FDA 510(k)

MCSCK838 CATHETER IN A TRAY (KIT)

K-Number: K821954 · 1982-07-14

ApplicantMedcomp
Decision Date1982-07-14
Product CodeLFJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MCSCK838 CATHETER IN A TRAY (KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 1982-07-14 under 510(k) number K821954. 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 MCSCK838 CATHETER IN A TRAY (KIT)?

MCSCK838 CATHETER IN A TRAY (KIT) is a medical device that received FDA 510(k) clearance on 1982-07-14. The listed applicant is Medcomp. The 510(k) number is K821954.

When did MCSCK838 CATHETER IN A TRAY (KIT) receive FDA 510(k) clearance?

MCSCK838 CATHETER IN A TRAY (KIT) received FDA 510(k) clearance on 1982-07-14, under 510(k) number K821954.

Who is the listed applicant for MCSCK838 CATHETER IN A TRAY (KIT)?

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

What is the FDA product code for MCSCK838 CATHETER IN A TRAY (KIT)?

The FDA product code for MCSCK838 CATHETER IN A TRAY (KIT) is LFJ.

Related Clinical Trials

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Other records listing Medcomp 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.

K123292T3K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICCK091954MICRO-STICK SETK092347PRO-PICC CTK091953PRO-PICCK090394VALVED TEARWAY INTRODUCER

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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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