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FDA 510(k)

AMPLATZER SIZING BALLOON

K-Number: K993248 · 2000-07-12

ApplicantAga Medical Corp.
Decision Date2000-07-12
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZER SIZING BALLOON 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 2000-07-12 under 510(k) number K993248. 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?

AMPLATZER SIZING BALLOON is a medical device that received FDA 510(k) clearance on 2000-07-12. The listed applicant is Aga Medical Corp.. The 510(k) number is K993248.

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

AMPLATZER SIZING BALLOON received FDA 510(k) clearance on 2000-07-12, under 510(k) number K993248.

Who is the listed applicant for AMPLATZER SIZING BALLOON?

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?

The FDA product code for AMPLATZER SIZING BALLOON is MJN.

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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

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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.

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