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FDA 510(k)

SUCTION CATHETER W/STERILE WATER

K-Number: K822510 · 1982-10-13

ApplicantMedine Dynacor
Decision Date1982-10-13
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUCTION CATHETER W/STERILE WATER is the device name listed in this FDA 510(k) record. The listed applicant is Medine Dynacor. It received FDA 510(k) clearance on 1982-10-13 under 510(k) number K822510. 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 SUCTION CATHETER W/STERILE WATER?

SUCTION CATHETER W/STERILE WATER is a medical device that received FDA 510(k) clearance on 1982-10-13. The listed applicant is Medine Dynacor. The 510(k) number is K822510.

When did SUCTION CATHETER W/STERILE WATER receive FDA 510(k) clearance?

SUCTION CATHETER W/STERILE WATER received FDA 510(k) clearance on 1982-10-13, under 510(k) number K822510.

Who is the listed applicant for SUCTION CATHETER W/STERILE WATER?

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

What is the FDA product code for SUCTION CATHETER W/STERILE WATER?

The FDA product code for SUCTION CATHETER W/STERILE WATER is GBX.

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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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