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FDA 510(k)

Deltaven Fast Flash Closed I.V. Catheter Systems

K-Number: K200373 · 2020-08-26

ApplicantDelta Med Spa
Decision Date2020-08-26
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Deltaven Fast Flash Closed I.V. Catheter Systems 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 2020-08-26 under 510(k) number K200373. 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 Fast Flash Closed I.V. Catheter Systems?

Deltaven Fast Flash Closed I.V. Catheter Systems is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Delta Med Spa. The 510(k) number is K200373.

When did Deltaven Fast Flash Closed I.V. Catheter Systems receive FDA 510(k) clearance?

Deltaven Fast Flash Closed I.V. Catheter Systems received FDA 510(k) clearance on 2020-08-26, under 510(k) number K200373.

Who is the listed applicant for Deltaven Fast Flash Closed I.V. Catheter Systems?

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 Fast Flash Closed I.V. Catheter Systems?

The FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems 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.

K171530Deltaven XiV Max, Deltaven XiV Max FF

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

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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