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FDA 510(k)

LOFRIC(R), LOFRIC(R) CATH-KIT

K-Number: K896750 · 1990-08-06

ApplicantAstra Meditec AB
Decision Date1990-08-06
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOFRIC(R), LOFRIC(R) CATH-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Astra Meditec AB. It received FDA 510(k) clearance on 1990-08-06 under 510(k) number K896750. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOFRIC(R), LOFRIC(R) CATH-KIT?

LOFRIC(R), LOFRIC(R) CATH-KIT is a medical device that received FDA 510(k) clearance on 1990-08-06. The listed applicant is Astra Meditec AB. The 510(k) number is K896750.

When did LOFRIC(R), LOFRIC(R) CATH-KIT receive FDA 510(k) clearance?

LOFRIC(R), LOFRIC(R) CATH-KIT received FDA 510(k) clearance on 1990-08-06, under 510(k) number K896750.

Who is the listed applicant for LOFRIC(R), LOFRIC(R) CATH-KIT?

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

What is the FDA product code for LOFRIC(R), LOFRIC(R) CATH-KIT?

The FDA product code for LOFRIC(R), LOFRIC(R) CATH-KIT is KOD.

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 Astra Meditec AB 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.

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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