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FDA 510(k)

AMPLATZER NOODLEWIRE GUIDEWIRE

K-Number: K053187 · 2006-04-27

ApplicantAga Medical Corp.
Decision Date2006-04-27
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZER NOODLEWIRE GUIDEWIRE 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 2006-04-27 under 510(k) number K053187. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLATZER NOODLEWIRE GUIDEWIRE?

AMPLATZER NOODLEWIRE GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Aga Medical Corp.. The 510(k) number is K053187.

When did AMPLATZER NOODLEWIRE GUIDEWIRE receive FDA 510(k) clearance?

AMPLATZER NOODLEWIRE GUIDEWIRE received FDA 510(k) clearance on 2006-04-27, under 510(k) number K053187.

Who is the listed applicant for AMPLATZER NOODLEWIRE GUIDEWIRE?

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 NOODLEWIRE GUIDEWIRE?

The FDA product code for AMPLATZER NOODLEWIRE GUIDEWIRE is DQX.

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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: DQX)

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.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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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