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FDA 510(k)

OSPREY Closed IV Catheter System (OspreyV2)

K-Number: K231626 · 2023-08-31

ApplicantSkydance Vascular, Inc.
Decision Date2023-08-31
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OSPREY Closed IV Catheter System (OspreyV2) is the device name listed in this FDA 510(k) record. The listed applicant is Skydance Vascular, Inc.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231626. 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 OSPREY Closed IV Catheter System (OspreyV2)?

OSPREY Closed IV Catheter System (OspreyV2) is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Skydance Vascular, Inc.. The 510(k) number is K231626.

When did OSPREY Closed IV Catheter System (OspreyV2) receive FDA 510(k) clearance?

OSPREY Closed IV Catheter System (OspreyV2) received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231626.

Who is the listed applicant for OSPREY Closed IV Catheter System (OspreyV2)?

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

What is the FDA product code for OSPREY Closed IV Catheter System (OspreyV2)?

The FDA product code for OSPREY Closed IV Catheter System (OspreyV2) is FOZ.

Other records listing Skydance Vascular, 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.

K250292OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)K223018OSPREY PERIPHERAL IV Catheter System

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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