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FDA 510(k)

PROLONG INTRAVASCULAR CATHETER

K-Number: K893965 · 1989-09-08

ApplicantBaxter Healthcare Corp
Decision Date1989-09-08
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PROLONG INTRAVASCULAR CATHETER 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 1989-09-08 under 510(k) number K893965. 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 PROLONG INTRAVASCULAR CATHETER?

PROLONG INTRAVASCULAR CATHETER is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K893965.

When did PROLONG INTRAVASCULAR CATHETER receive FDA 510(k) clearance?

PROLONG INTRAVASCULAR CATHETER received FDA 510(k) clearance on 1989-09-08, under 510(k) number K893965.

Who is the listed applicant for PROLONG INTRAVASCULAR CATHETER?

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 PROLONG INTRAVASCULAR CATHETER?

The FDA product code for PROLONG INTRAVASCULAR CATHETER is FOZ.

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Other records listing Baxter Healthcare 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.

K190910PrisMax System Version 2K163530PrisMax Control UnitK132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSK130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFOK123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL SK123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET

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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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