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FDA 510(k)

JMS SAFE WING CATH (SWC)

K-Number: K121488 · 2013-03-05

ApplicantJMS North America Corporation
Decision Date2013-03-05
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JMS SAFE WING CATH (SWC) is the device name listed in this FDA 510(k) record. The listed applicant is JMS North America Corporation. It received FDA 510(k) clearance on 2013-03-05 under 510(k) number K121488. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JMS SAFE WING CATH (SWC)?

JMS SAFE WING CATH (SWC) is a medical device that received FDA 510(k) clearance on 2013-03-05. The listed applicant is JMS North America Corporation. The 510(k) number is K121488.

When did JMS SAFE WING CATH (SWC) receive FDA 510(k) clearance?

JMS SAFE WING CATH (SWC) received FDA 510(k) clearance on 2013-03-05, under 510(k) number K121488.

Who is the listed applicant for JMS SAFE WING CATH (SWC)?

The FDA 510(k) record lists JMS North America Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JMS SAFE WING CATH (SWC)?

The FDA product code for JMS SAFE WING CATH (SWC) is FOZ.

Other records listing JMS North America Corporation 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.

K251877JMS CAVEO A.V. Fistula Needle SetK172499NEOSHIELDK112178JMS APHERESIS NEEDLE SET WINGEATER(R) V2K111948WINGEATER V2K110157SYSLOC MINI V3

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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