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FDA 510(k)

FLUID ADMIN. SET AFS-1C

K-Number: K831348 · 1983-05-27

ApplicantLinton Biomed Corp.
Decision Date1983-05-27
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLUID ADMIN. SET AFS-1C is the device name listed in this FDA 510(k) record. The listed applicant is Linton Biomed Corp.. It received FDA 510(k) clearance on 1983-05-27 under 510(k) number K831348. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUID ADMIN. SET AFS-1C?

FLUID ADMIN. SET AFS-1C is a medical device that received FDA 510(k) clearance on 1983-05-27. The listed applicant is Linton Biomed Corp.. The 510(k) number is K831348.

When did FLUID ADMIN. SET AFS-1C receive FDA 510(k) clearance?

FLUID ADMIN. SET AFS-1C received FDA 510(k) clearance on 1983-05-27, under 510(k) number K831348.

Who is the listed applicant for FLUID ADMIN. SET AFS-1C?

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

What is the FDA product code for FLUID ADMIN. SET AFS-1C?

The FDA product code for FLUID ADMIN. SET AFS-1C is DRS.

Related Clinical Trials

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.

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Other records listing Linton Biomed Corp. 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.

K841772HEPARIN CAP, INJECTION CAP MALE LUER-K820202CONTINUOUS FLUSH DEVICE/FDIK820201DISPOS. MONITORING SYS/LI ET ALK820203FLUID ADMINISTRATIVE SET, AFI

Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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