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FDA 510(k)

HYPODERMIC SYRINGES & NEEDLES

K-Number: K834548 · 1984-03-06

ApplicantCordis Corp.
Decision Date1984-03-06
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HYPODERMIC SYRINGES & NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1984-03-06 under 510(k) number K834548. 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 HYPODERMIC SYRINGES & NEEDLES?

HYPODERMIC SYRINGES & NEEDLES is a medical device that received FDA 510(k) clearance on 1984-03-06. The listed applicant is Cordis Corp.. The 510(k) number is K834548.

When did HYPODERMIC SYRINGES & NEEDLES receive FDA 510(k) clearance?

HYPODERMIC SYRINGES & NEEDLES received FDA 510(k) clearance on 1984-03-06, under 510(k) number K834548.

Who is the listed applicant for HYPODERMIC SYRINGES & NEEDLES?

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

What is the FDA product code for HYPODERMIC SYRINGES & NEEDLES?

The FDA product code for HYPODERMIC SYRINGES & NEEDLES is FMF.

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Other records listing Cordis Corp. as applicant

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K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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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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