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FDA 510(k)

Deltaven XiV Max, Deltaven XiV Max FF

K-Number: K171530 · 2017-12-21

ApplicantDelta Med Spa
Decision Date2017-12-21
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Deltaven XiV Max, Deltaven XiV Max FF is the device name listed in this FDA 510(k) record. The listed applicant is Delta Med Spa. It received FDA 510(k) clearance on 2017-12-21 under 510(k) number K171530. 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 Deltaven XiV Max, Deltaven XiV Max FF?

Deltaven XiV Max, Deltaven XiV Max FF is a medical device that received FDA 510(k) clearance on 2017-12-21. The listed applicant is Delta Med Spa. The 510(k) number is K171530.

When did Deltaven XiV Max, Deltaven XiV Max FF receive FDA 510(k) clearance?

Deltaven XiV Max, Deltaven XiV Max FF received FDA 510(k) clearance on 2017-12-21, under 510(k) number K171530.

Who is the listed applicant for Deltaven XiV Max, Deltaven XiV Max FF?

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

What is the FDA product code for Deltaven XiV Max, Deltaven XiV Max FF?

The FDA product code for Deltaven XiV Max, Deltaven XiV Max FF is FOZ.

Other records listing Delta Med Spa 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.

K200373Deltaven Fast Flash Closed I.V. Catheter Systems

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.

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.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure Limited

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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