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FDA 510(k)

RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER

K-Number: K001143 · 2000-07-07

ApplicantRochester Medical Corp.
Decision Date2000-07-07
Product CodeMJC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL 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 2000-07-07 under 510(k) number K001143. The device is classified under product code MJC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER?

RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER is a medical device that received FDA 510(k) clearance on 2000-07-07. The listed applicant is Rochester Medical Corp.. The 510(k) number is K001143.

When did RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER receive FDA 510(k) clearance?

RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER received FDA 510(k) clearance on 2000-07-07, under 510(k) number K001143.

Who is the listed applicant for RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL 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 RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER?

The FDA product code for RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER is MJC.

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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 KITK000723HYDROPHILIC 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 CATHETERK970704PERSONAL CATHETER

View all 13 devices →

Related Devices (Code: MJC)

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.

K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd.K040658BARDEX I.C. LATEX FOLEY CATHETERC.R. Bard, Inc.K033477HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KITRochester Medical Corp.K000251SPECTRUM SILICONE FOLEY CATHETERCook Urological, Inc.K993464BARDEX I.C. PEDIATRIC FOLEY CATHETERC.R. Bard, Inc.K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETERBard Medical Div.

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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