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FDA 510(k)

CAPD CATHETER ADAPTER

K-Number: K810683 · 1981-05-08

ApplicantAmerican Mcgaw
Decision Date1981-05-08
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CAPD CATHETER ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is American Mcgaw. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K810683. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPD CATHETER ADAPTER?

CAPD CATHETER ADAPTER is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is American Mcgaw. The 510(k) number is K810683.

When did CAPD CATHETER ADAPTER receive FDA 510(k) clearance?

CAPD CATHETER ADAPTER received FDA 510(k) clearance on 1981-05-08, under 510(k) number K810683.

Who is the listed applicant for CAPD CATHETER ADAPTER?

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

What is the FDA product code for CAPD CATHETER ADAPTER?

The FDA product code for CAPD CATHETER ADAPTER is FKX.

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Other records listing American Mcgaw 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.

K853549MCGAW/DROP WATCH FLOW MONITORK843639ADD-A-VIAL SOLUTION TRANSFER DEVICEK843954MIXING CONTAINERK841729ACCUPRO ENTERAL FEEDING PUMPK840388PAB IV CONTAINERK840212CONCENTRATED PLATELET ADMIN. SET

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Related Devices (Code: FKX)

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.

K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5)Simergent, LLCK243371Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1Byonyks Pvt, Ltd.K220935Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone AppIren-Medical, Ltd.K222318Fresenius Liberty Select CyclerFresenius Medical Care Renal Therapies Group, LLCK212522Lilliput APD SystemFresenius Medical Care Renal Therapies Group, LLCK212658CloudCath Peritoneal Dialysis Drain Set Monitoring SystemCloudcath

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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