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FDA 510(k)

SF SH CATHETER, MODEL R65-945

K-Number: K013437 · 2001-11-19

ApplicantA & A Medical, Inc.
Decision Date2001-11-19
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SF SH CATHETER, MODEL R65-945 is the device name listed in this FDA 510(k) record. The listed applicant is A & A Medical, Inc.. It received FDA 510(k) clearance on 2001-11-19 under 510(k) number K013437. 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 SF SH CATHETER, MODEL R65-945?

SF SH CATHETER, MODEL R65-945 is a medical device that received FDA 510(k) clearance on 2001-11-19. The listed applicant is A & A Medical, Inc.. The 510(k) number is K013437.

When did SF SH CATHETER, MODEL R65-945 receive FDA 510(k) clearance?

SF SH CATHETER, MODEL R65-945 received FDA 510(k) clearance on 2001-11-19, under 510(k) number K013437.

Who is the listed applicant for SF SH CATHETER, MODEL R65-945?

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

What is the FDA product code for SF SH CATHETER, MODEL R65-945?

The FDA product code for SF SH CATHETER, MODEL R65-945 is LKF.

Related Clinical Trials

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Other records listing A & A 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.

K013491HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948K003949TACKER, MODEL R65-933K011512MMODIFICATION TO LAMINARIAK010510BALLOON CANNULA, SHORT, MODEL R65-985; BALLOON CANNULA, LONG, MODEL R65-985-1K010789CANNULA, SURGICAL GENERAL & PLASTIC SURGERY, MODELR65-995, R65-995-1, R65-995-2, R65-997, R65-997-1K010056UTERINE MANIPULATOR INJECTOR CANNULA, STERILE, MODEL R 57-450

View all 23 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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