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FDA 510(k)

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

K-Number: K083919 · 2009-03-13

ApplicantInvatec Innovative Technologies, S.R.L.
Decision Date2009-03-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Invatec Innovative Technologies, S.R.L.. It received FDA 510(k) clearance on 2009-03-13 under 510(k) number K083919. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER?

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2009-03-13. The listed applicant is Invatec Innovative Technologies, S.R.L.. The 510(k) number is K083919.

When did AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER receive FDA 510(k) clearance?

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER received FDA 510(k) clearance on 2009-03-13, under 510(k) number K083919.

Who is the listed applicant for AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER?

The FDA 510(k) record lists Invatec Innovative Technologies, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER?

The FDA product code for AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER is DQY.

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Other records listing Invatec Innovative Technologies, S.R.L. 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.

K052791MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERK051917DIVER C.E. CATHETERK050756SKIPPER AND SKIPPER RACE GUIDEWIREK050276DIVER C.E. CATHETERK050073MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETERK042624AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

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Related Devices (Code: DQY)

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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