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FDA 510(k)

KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER

K-Number: K911242 · 1991-04-25

ApplicantKendall Healthcare Products Co. Div.Of Tyco Health
Decision Date1991-04-25
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KENDALL PEDIATRIC ULTRAMER POLYURETHANE 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 1991-04-25 under 510(k) number K911242. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER?

KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER is a medical device that received FDA 510(k) clearance on 1991-04-25. The listed applicant is Kendall Healthcare Products Co. Div.Of Tyco Health. The 510(k) number is K911242.

When did KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER receive FDA 510(k) clearance?

KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER received FDA 510(k) clearance on 1991-04-25, under 510(k) number K911242.

Who is the listed applicant for KENDALL PEDIATRIC ULTRAMER POLYURETHANE 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 PEDIATRIC ULTRAMER POLYURETHANE CATHETER?

The FDA product code for KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER is KOD.

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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: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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