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FDA 510(k)

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER

K-Number: K982970 · 1998-10-28

ApplicantMri Manufacturing and Research, Inc.
Decision Date1998-10-28
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Mri Manufacturing and Research, Inc.. It received FDA 510(k) clearance on 1998-10-28 under 510(k) number K982970. 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 MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER?

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER is a medical device that received FDA 510(k) clearance on 1998-10-28. The listed applicant is Mri Manufacturing and Research, Inc.. The 510(k) number is K982970.

When did MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER receive FDA 510(k) clearance?

MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER received FDA 510(k) clearance on 1998-10-28, under 510(k) number K982970.

Who is the listed applicant for MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER?

The FDA 510(k) record lists Mri Manufacturing and Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER?

The FDA product code for MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER is EZL.

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 Mri Manufacturing and Research, Inc. 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.

K083685ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285K944676MRI'S ALL SILICONE FOLEY CATHETER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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