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FDA 510(k)

INFUS. SETS-9120-50 CM & 9121-100 CM,EXT

K-Number: K822775 · 1982-11-03

ApplicantCardiac Pacemakers, Inc.
Decision Date1982-11-03
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INFUS. SETS-9120-50 CM & 9121-100 CM,EXT is the device name listed in this FDA 510(k) record. The listed applicant is Cardiac Pacemakers, Inc.. It received FDA 510(k) clearance on 1982-11-03 under 510(k) number K822775. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFUS. SETS-9120-50 CM & 9121-100 CM,EXT?

INFUS. SETS-9120-50 CM & 9121-100 CM,EXT is a medical device that received FDA 510(k) clearance on 1982-11-03. The listed applicant is Cardiac Pacemakers, Inc.. The 510(k) number is K822775.

When did INFUS. SETS-9120-50 CM & 9121-100 CM,EXT receive FDA 510(k) clearance?

INFUS. SETS-9120-50 CM & 9121-100 CM,EXT received FDA 510(k) clearance on 1982-11-03, under 510(k) number K822775.

Who is the listed applicant for INFUS. SETS-9120-50 CM & 9121-100 CM,EXT?

The FDA 510(k) record lists Cardiac Pacemakers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFUS. SETS-9120-50 CM & 9121-100 CM,EXT?

The FDA product code for INFUS. SETS-9120-50 CM & 9121-100 CM,EXT is FPA.

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Other records listing Cardiac Pacemakers, Inc. as applicant

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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