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FDA 510(k)

ALL SILICONE FOLEY CATHETER

K-Number: K896053 · 1990-02-12

ApplicantRochester Medical Corp.
Decision Date1990-02-12
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL SILICONE FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Rochester Medical Corp.. It received FDA 510(k) clearance on 1990-02-12 under 510(k) number K896053. 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 ALL SILICONE FOLEY CATHETER?

ALL SILICONE FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1990-02-12. The listed applicant is Rochester Medical Corp.. The 510(k) number is K896053.

When did ALL SILICONE FOLEY CATHETER receive FDA 510(k) clearance?

ALL SILICONE FOLEY CATHETER received FDA 510(k) clearance on 1990-02-12, under 510(k) number K896053.

Who is the listed applicant for ALL SILICONE FOLEY CATHETER?

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

What is the FDA product code for ALL SILICONE FOLEY CATHETER?

The FDA product code for ALL SILICONE FOLEY CATHETER is KOD.

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 Rochester Medical 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.

K122785HYDROSIL; MAGIC; PERSONAL CATHETERK033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITK001143RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETERK000723HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)K981612ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETERK971627SILICONE ANTIBACTERIAL FOLEY CATHETER

View all 13 devices →

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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