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FDA 510(k)

CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH

K-Number: K881215 · 1988-06-13

ApplicantBaxter Healthcare Corp
Decision Date1988-06-13
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-06-13 under 510(k) number K881215. 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 CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH?

CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH is a medical device that received FDA 510(k) clearance on 1988-06-13. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K881215.

When did CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH receive FDA 510(k) clearance?

CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH received FDA 510(k) clearance on 1988-06-13, under 510(k) number K881215.

Who is the listed applicant for CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH?

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

What is the FDA product code for CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH?

The FDA product code for CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH is FOZ.

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Other records listing Baxter Healthcare Corp as applicant

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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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