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FDA 510(k)

MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR

K-Number: K850601 · 1985-04-25

ApplicantLife-Tech Intl., Inc.
Decision Date1985-04-25
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1985-04-25 under 510(k) number K850601. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR?

MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR is a medical device that received FDA 510(k) clearance on 1985-04-25. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K850601.

When did MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR receive FDA 510(k) clearance?

MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR received FDA 510(k) clearance on 1985-04-25, under 510(k) number K850601.

Who is the listed applicant for MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR?

The FDA 510(k) record lists Life-Tech Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR?

The FDA product code for MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR is FAP.

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Other records listing Life-Tech Intl., 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.

K001129PROLONG, MODELS PL50, PL100, PL150K955031MAXISTIMK954505EZ STIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

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Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., 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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