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)

OCCLUSION BALLOON CATHETER

K-Number: K132990 · 2013-10-22

ApplicantBoston Scientific Corp
Decision Date2013-10-22
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OCCLUSION BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2013-10-22 under 510(k) number K132990. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCCLUSION BALLOON CATHETER?

OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2013-10-22. The listed applicant is Boston Scientific Corp. The 510(k) number is K132990.

When did OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 2013-10-22, under 510(k) number K132990.

Who is the listed applicant for OCCLUSION BALLOON CATHETER?

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

What is the FDA product code for OCCLUSION BALLOON CATHETER?

The FDA product code for OCCLUSION BALLOON CATHETER is MJN.

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 Boston Scientific 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.

K243245IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)K231328LUX-Dx II (M302); LUX-Dx II+ (M312)K133566ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUSK133208INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEMK131700SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARESK131914OFFROAD RE-ENTRY CATHETER SYSTEM

View all 414 devices →

Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, 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.

↑