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FDA 510(k)

KENDALL SAFETRAK(TM) HIGH FLOW CATHETER

K-Number: K903732 · 1990-10-03

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1990-10-03
Product CodeFOZ
Advisory CommitteeHO
DecisionUnknown

Device Summary

KENDALL SAFETRAK(TM) HIGH FLOW CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. It received FDA 510(k) clearance on 1990-10-03 under 510(k) number K903732. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the KENDALL SAFETRAK(TM) HIGH FLOW CATHETER?

KENDALL SAFETRAK(TM) HIGH FLOW CATHETER is a medical device that received FDA 510(k) clearance on 1990-10-03. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K903732.

When did KENDALL SAFETRAK(TM) HIGH FLOW CATHETER receive FDA 510(k) clearance?

KENDALL SAFETRAK(TM) HIGH FLOW CATHETER received FDA 510(k) clearance on 1990-10-03, under 510(k) number K903732.

Who is the listed applicant for KENDALL SAFETRAK(TM) HIGH FLOW CATHETER?

The FDA 510(k) record lists Kendall Healthcare Products Co. Div.Of Tyco Health as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KENDALL SAFETRAK(TM) HIGH FLOW CATHETER?

The FDA product code for KENDALL SAFETRAK(TM) HIGH FLOW CATHETER is FOZ.

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Other records listing Kendall Healthcare Products Co. Div.Of Tyco Health 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.

K973763KENDALL CURITY IODOFORM PACKING STRIPK973511KENDALL CURITY PETROLATUM GAUZEK973507KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)K973619KENDALL CURITY NON-ADHERING DRESSINGK973509KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSINGK973546KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

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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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