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FDA 510(k)

NON-KOR ACCESS KITS

K-Number: K852831 · 1985-09-19

ApplicantCreative Care Systems, Inc.
Decision Date1985-09-19
Product CodeFMI
Advisory CommitteeHO
DecisionUnknown

Device Summary

NON-KOR ACCESS KITS is the device name listed in this FDA 510(k) record. The listed applicant is Creative Care Systems, Inc.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K852831. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the NON-KOR ACCESS KITS?

NON-KOR ACCESS KITS is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Creative Care Systems, Inc.. The 510(k) number is K852831.

When did NON-KOR ACCESS KITS receive FDA 510(k) clearance?

NON-KOR ACCESS KITS received FDA 510(k) clearance on 1985-09-19, under 510(k) number K852831.

Who is the listed applicant for NON-KOR ACCESS KITS?

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

What is the FDA product code for NON-KOR ACCESS KITS?

The FDA product code for NON-KOR ACCESS KITS is FMI.

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 Creative Care Systems, 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.

K861406NON-KOR WINGED INFUSION SETSK850888PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CVK850887DRESSING CHANGE KITK841742NON-CORING NEEDLEK840919DAYPAK SYS VII CATHETER CARE KITK840681DAYPAK SYSTEM III CATHETER CARE KIT

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Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT 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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