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FDA 510(k)

COMFORT SLEEVED ALL SILICONE FOLEY CATHETER

K-Number: K905042 · 1991-01-18

ApplicantRochester Medical Corp.
Decision Date1991-01-18
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COMFORT SLEEVED 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 1991-01-18 under 510(k) number K905042. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT SLEEVED ALL SILICONE FOLEY CATHETER?

COMFORT SLEEVED ALL SILICONE FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Rochester Medical Corp.. The 510(k) number is K905042.

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

COMFORT SLEEVED ALL SILICONE FOLEY CATHETER received FDA 510(k) clearance on 1991-01-18, under 510(k) number K905042.

Who is the listed applicant for COMFORT SLEEVED 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 COMFORT SLEEVED ALL SILICONE FOLEY CATHETER?

The FDA product code for COMFORT SLEEVED ALL SILICONE FOLEY CATHETER is EZL.

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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: EZL)

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.

K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies,K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd.K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd.K241424InnoCare Specialty Foley CatheterInnocare Urologics, LLCK232469Rüsch Latex Gold Foley CatheterTeleflexmedical, 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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