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FDA 510(k)

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER

K-Number: K941488 · 1994-11-30

ApplicantMedical Technology Development Corp.
Decision Date1994-11-30
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Technology Development Corp.. It received FDA 510(k) clearance on 1994-11-30 under 510(k) number K941488. 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 DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER?

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER is a medical device that received FDA 510(k) clearance on 1994-11-30. The listed applicant is Medical Technology Development Corp.. The 510(k) number is K941488.

When did DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER receive FDA 510(k) clearance?

DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER received FDA 510(k) clearance on 1994-11-30, under 510(k) number K941488.

Who is the listed applicant for DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER?

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

What is the FDA product code for DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER?

The FDA product code for DEVMED DOUBLE-BALLOON UROLOGICAL 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 Medical Technology Development 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.

K862315FYODOROV COLLAGEN CORNEAL SHIELDK863725CATARACT DIAMOND KNIFEK863727FIXATION INSTRUMENTSK863726INSTRUMENT STERILIZATION TRAY

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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