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FDA 510(k)

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER

K-Number: K980919 · 1998-03-31

ApplicantFortune Medical Instrument Corp.
Decision Date1998-03-31
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Fortune Medical Instrument Corp.. It received FDA 510(k) clearance on 1998-03-31 under 510(k) number K980919. 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 ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER?

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER is a medical device that received FDA 510(k) clearance on 1998-03-31. The listed applicant is Fortune Medical Instrument Corp.. The 510(k) number is K980919.

When did ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER receive FDA 510(k) clearance?

ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER received FDA 510(k) clearance on 1998-03-31, under 510(k) number K980919.

Who is the listed applicant for ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER?

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

What is the FDA product code for ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER?

The FDA product code for ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER is EZL.

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Other records listing Fortune Medical Instrument 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.

K022112FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020K021193FORTUNE SILICONE VACUUM SUCTION, MODEL #1300K021142ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865K014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890K980917ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR

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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