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FDA 510(k)

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)

K-Number: K953034 · 1995-08-29

ApplicantAckrad Laboratories
Decision Date1995-08-29
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1995-08-29 under 510(k) number K953034. 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(61-3005, 61-3007, 61-3605, 61-3607)?

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) is a medical device that received FDA 510(k) clearance on 1995-08-29. The listed applicant is Ackrad Laboratories. The 510(k) number is K953034.

When did H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) receive FDA 510(k) clearance?

H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) received FDA 510(k) clearance on 1995-08-29, under 510(k) number K953034.

Who is the listed applicant for H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)?

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(61-3005, 61-3007, 61-3605, 61-3607)?

The FDA product code for H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607) is LKF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

View all 42 devices →

Related Devices (Code: LKF)

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.

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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