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FDA 510(k)

PHYCON ALL SILICONE BALLOON CATHETER

K-Number: K894883 · 1990-04-25

ApplicantVitaid, Ltd.
Decision Date1990-04-25
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PHYCON ALL SILICONE BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Vitaid, Ltd.. It received FDA 510(k) clearance on 1990-04-25 under 510(k) number K894883. 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 PHYCON ALL SILICONE BALLOON CATHETER?

PHYCON ALL SILICONE BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1990-04-25. The listed applicant is Vitaid, Ltd.. The 510(k) number is K894883.

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

PHYCON ALL SILICONE BALLOON CATHETER received FDA 510(k) clearance on 1990-04-25, under 510(k) number K894883.

Who is the listed applicant for PHYCON ALL SILICONE BALLOON CATHETER?

The FDA 510(k) record lists Vitaid, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHYCON ALL SILICONE BALLOON CATHETER?

The FDA product code for PHYCON ALL SILICONE BALLOON CATHETER is EZL.

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Other records listing Vitaid, Ltd. 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.

K050803PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBESK932647WIRE REINFORCED ENDOTRACHEAL TUBEK901738SELFCATHK894794AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMPK894669LASER SHIELDING TUBEK894337UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM

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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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