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FDA 510(k)

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER

K-Number: K043241 · 2004-12-23

ApplicantAstra Tech, Inc.
Decision Date2004-12-23
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech, Inc.. It received FDA 510(k) clearance on 2004-12-23 under 510(k) number K043241. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER?

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER is a medical device that received FDA 510(k) clearance on 2004-12-23. The listed applicant is Astra Tech, Inc.. The 510(k) number is K043241.

When did LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER receive FDA 510(k) clearance?

LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER received FDA 510(k) clearance on 2004-12-23, under 510(k) number K043241.

Who is the listed applicant for LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER?

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

What is the FDA product code for LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER?

The FDA product code for LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER is GBM.

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Other records listing Astra Tech, 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.

K122078LOFRIC PRIMO, LOFRIC HYDRO-KITK120338ATLANTIS IN ZIRCONIA FOR DENTSPLY ANKYLOS IMPLANT, ATLANTIS LATER ABUTMENT IN ZIRCONIAK113003ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT...K112138ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANTK110356ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENTK110640ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT

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Related Devices (Code: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec LimitedK211436Intermittent Catheter (Not Finalized)Hollister IncorporatedK200820SpeediCath Compact SetColoplastK192904SpeediCath Compact SetColoplastK200142SpeediCath SoftColoplast

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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