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)

AMPLATZER SIZING BALLOON II

K-Number: K053440 · 2005-12-30

ApplicantAga Medical Corp.
Decision Date2005-12-30
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZER SIZING BALLOON II is the device name listed in this FDA 510(k) record. The listed applicant is Aga Medical Corp.. It received FDA 510(k) clearance on 2005-12-30 under 510(k) number K053440. 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 AMPLATZER SIZING BALLOON II?

AMPLATZER SIZING BALLOON II is a medical device that received FDA 510(k) clearance on 2005-12-30. The listed applicant is Aga Medical Corp.. The 510(k) number is K053440.

When did AMPLATZER SIZING BALLOON II receive FDA 510(k) clearance?

AMPLATZER SIZING BALLOON II received FDA 510(k) clearance on 2005-12-30, under 510(k) number K053440.

Who is the listed applicant for AMPLATZER SIZING BALLOON II?

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

What is the FDA product code for AMPLATZER SIZING BALLOON II?

The FDA product code for AMPLATZER SIZING BALLOON II 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 Aga Medical 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.

K113658AMPLATZER VASCULAR PLUG 4K093476AMPLATZER TORQ VUE 2 DELIVERY SHEATH MODEL 9-TV2-05F120, MODEL 9-TV2-06F120, MODELTV-2-07F120K091793AMPLATZER TORQVUE 3 DELIVERY SHEATH, MODEL 9-TV3-08F104, 9-TV3-08F54K083214AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100K080994AMPLATZER TORQVUE EXCHANGE SYSTEMK080757AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM

View all 14 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.

↑