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FDA 510(k)

H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007

K-Number: K020951 · 2002-04-16

ApplicantAckrad Laboratories
Decision Date2002-04-16
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 2002-04-16 under 510(k) number K020951. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007?

H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 is a medical device that received FDA 510(k) clearance on 2002-04-16. The listed applicant is Ackrad Laboratories. The 510(k) number is K020951.

When did H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 receive FDA 510(k) clearance?

H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 received FDA 510(k) clearance on 2002-04-16, under 510(k) number K020951.

Who is the listed applicant for H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007?

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

What is the FDA product code for H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007?

The FDA product code for H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007 is LKF.

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Other records listing Ackrad Laboratories 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.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATIONK952542ACKRAD ESOPHAGEAL BALLOON CATHETER SET

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K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, 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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