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FDA 510(k)

CAPD - CATHETER ADAPTER

K-Number: K831716 · 1983-06-24

ApplicantAmerican Mcgaw
Decision Date1983-06-24
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 1983-06-24 under 510(k) number K831716. 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 1983-06-24. The listed applicant is American Mcgaw. The 510(k) number is K831716.

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

CAPD - CATHETER ADAPTER received FDA 510(k) clearance on 1983-06-24, under 510(k) number K831716.

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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