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FDA 510(k)

CHARGER PTA BALLON DILATATION CATHETER

K-Number: K112697 · 2011-11-30

ApplicantBoston Scientific
Decision Date2011-11-30
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CHARGER PTA BALLON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2011-11-30 under 510(k) number K112697. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHARGER PTA BALLON DILATATION CATHETER?

CHARGER PTA BALLON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2011-11-30. The listed applicant is Boston Scientific. The 510(k) number is K112697.

When did CHARGER PTA BALLON DILATATION CATHETER receive FDA 510(k) clearance?

CHARGER PTA BALLON DILATATION CATHETER received FDA 510(k) clearance on 2011-11-30, under 510(k) number K112697.

Who is the listed applicant for CHARGER PTA BALLON DILATATION CATHETER?

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

What is the FDA product code for CHARGER PTA BALLON DILATATION CATHETER?

The FDA product code for CHARGER PTA BALLON DILATATION CATHETER is LIT.

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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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