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FDA 510(k)

LIFETEK IUI CATHETER

K-Number: K921518 · 1994-05-10

ApplicantLifetek Medical, Inc.
Decision Date1994-05-10
Product CodeMFD
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LIFETEK IUI CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Lifetek Medical, Inc.. It received FDA 510(k) clearance on 1994-05-10 under 510(k) number K921518. The device is classified under product code MFD. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFETEK IUI CATHETER?

LIFETEK IUI CATHETER is a medical device that received FDA 510(k) clearance on 1994-05-10. The listed applicant is Lifetek Medical, Inc.. The 510(k) number is K921518.

When did LIFETEK IUI CATHETER receive FDA 510(k) clearance?

LIFETEK IUI CATHETER received FDA 510(k) clearance on 1994-05-10, under 510(k) number K921518.

Who is the listed applicant for LIFETEK IUI CATHETER?

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

What is the FDA product code for LIFETEK IUI CATHETER?

The FDA product code for LIFETEK IUI CATHETER is MFD.

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 Lifetek Medical, 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.

K992308OOCYTE RETRIEVAL NEEDLE SET, MODEL 90138

Related Devices (Code: MFD)

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.

K021438INSEMINATION CATHETER, MODEL 320301Labotect Labor-Technik GottingenK012935THECURVE, ITEM 507Select Medical Systems, Inc.K984306`THE INSEMINATOR' (PROPOSED)Wallach Surgical Devices, Inc.K982630MEDWORKS VISUALIZATION INSEMINATION CATHETERMedworks Corp.K982628MEDWORKS INSEMINATION CATHETERMedworks Corp.K980061EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTERRocket Medical Plc

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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