Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INTRAUTERINE HEMOSTASIS BALLOON STENT

K-Number: K863439 · 1987-06-02

ApplicantMentor Corp.
Decision Date1987-06-02
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRAUTERINE HEMOSTASIS BALLOON STENT is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1987-06-02 under 510(k) number K863439. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAUTERINE HEMOSTASIS BALLOON STENT?

INTRAUTERINE HEMOSTASIS BALLOON STENT is a medical device that received FDA 510(k) clearance on 1987-06-02. The listed applicant is Mentor Corp.. The 510(k) number is K863439.

When did INTRAUTERINE HEMOSTASIS BALLOON STENT receive FDA 510(k) clearance?

INTRAUTERINE HEMOSTASIS BALLOON STENT received FDA 510(k) clearance on 1987-06-02, under 510(k) number K863439.

Who is the listed applicant for INTRAUTERINE HEMOSTASIS BALLOON STENT?

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

What is the FDA product code for INTRAUTERINE HEMOSTASIS BALLOON STENT?

The FDA product code for INTRAUTERINE HEMOSTASIS BALLOON STENT is KNA.

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 Mentor Corp. 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

View all 61 devices →

Related Devices (Code: KNA)

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/Gyn

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.

↑