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FDA 510(k)

COEUR CONTROL SYRINGE

K-Number: K874579 · 1988-01-19

ApplicantCoeur Laboratories, Inc.
Decision Date1988-01-19
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COEUR CONTROL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Laboratories, Inc.. It received FDA 510(k) clearance on 1988-01-19 under 510(k) number K874579. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COEUR CONTROL SYRINGE?

COEUR CONTROL SYRINGE is a medical device that received FDA 510(k) clearance on 1988-01-19. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K874579.

When did COEUR CONTROL SYRINGE receive FDA 510(k) clearance?

COEUR CONTROL SYRINGE received FDA 510(k) clearance on 1988-01-19, under 510(k) number K874579.

Who is the listed applicant for COEUR CONTROL SYRINGE?

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

What is the FDA product code for COEUR CONTROL SYRINGE?

The FDA product code for COEUR CONTROL SYRINGE is FMF.

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Other records listing Coeur Laboratories, Inc. 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.

K971712COEUR 130 ML ANGIOGRAPHIC SYRINGEK965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGEK885138CAPILLARY TUBE, BLOOD COLLECTIONK88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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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