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FDA 510(k)

AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022

K-Number: K071699 · 2007-08-15

ApplicantAga Medical Corp.
Decision Date2007-08-15
Product CodeKRD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 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 2007-08-15 under 510(k) number K071699. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022?

AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Aga Medical Corp.. The 510(k) number is K071699.

When did AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 receive FDA 510(k) clearance?

AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071699.

Who is the listed applicant for AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022?

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 VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022?

The FDA product code for AMPLATZER VASCULAR PLUG II, MODELS AVP2-003, AVP2-018, AVP2-020, AVP2-022 is KRD.

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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: KRD)

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.

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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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