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FDA 510(k)

TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

K-Number: K082997 · 2009-04-15

ApplicantTerumo Medical Corp.
Decision Date2009-04-15
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2009-04-15 under 510(k) number K082997. 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 TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER?

TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER is a medical device that received FDA 510(k) clearance on 2009-04-15. The listed applicant is Terumo Medical Corp.. The 510(k) number is K082997.

When did TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER receive FDA 510(k) clearance?

TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER received FDA 510(k) clearance on 2009-04-15, under 510(k) number K082997.

Who is the listed applicant for TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER?

The FDA 510(k) record lists Terumo Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER?

The FDA product code for TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER is FOZ.

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Other records listing Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK090040RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP)

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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

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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