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FDA 510(k)

KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER

K-Number: K973546 · 1997-11-07

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1997-11-07
Product CodeEZD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENDALL FAST-CATH PRE LUBRICATED URETHRAL 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 1997-11-07 under 510(k) number K973546. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER?

KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER is a medical device that received FDA 510(k) clearance on 1997-11-07. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K973546.

When did KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER receive FDA 510(k) clearance?

KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER received FDA 510(k) clearance on 1997-11-07, under 510(k) number K973546.

Who is the listed applicant for KENDALL FAST-CATH PRE LUBRICATED URETHRAL 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 FAST-CATH PRE LUBRICATED URETHRAL CATHETER?

The FDA product code for KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER is EZD.

Related Clinical Trials

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.

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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 DRESSINGK970266KENDALL HYDROPHILIC POWDER WOUND DRESSING

View all 66 devices →

Related Devices (Code: EZD)

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.

K261418Liquick X-treme, Liquick X-treme PlusTeleflex MedicalK260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).ConvatecK261658LoFric Origo Pro CoudéWellspect ABK262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

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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