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FDA 510(k)

CATHETER, IRRIGATION

K-Number: K770706 · 1977-05-06

ApplicantMallinckrodt Critical Care
Decision Date1977-05-06
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CATHETER, IRRIGATION is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1977-05-06 under 510(k) number K770706. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, IRRIGATION?

CATHETER, IRRIGATION is a medical device that received FDA 510(k) clearance on 1977-05-06. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K770706.

When did CATHETER, IRRIGATION receive FDA 510(k) clearance?

CATHETER, IRRIGATION received FDA 510(k) clearance on 1977-05-06, under 510(k) number K770706.

Who is the listed applicant for CATHETER, IRRIGATION?

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

What is the FDA product code for CATHETER, IRRIGATION?

The FDA product code for CATHETER, IRRIGATION is GBX.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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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