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FDA 510(k)

PTA BALLOON CATHETER

K-Number: K915349 · 1992-02-11

ApplicantSchneider Intl., Ltd.
Decision Date1992-02-11
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Schneider Intl., Ltd.. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K915349. 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 PTA BALLOON CATHETER?

PTA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is Schneider Intl., Ltd.. The 510(k) number is K915349.

When did PTA BALLOON CATHETER receive FDA 510(k) clearance?

PTA BALLOON CATHETER received FDA 510(k) clearance on 1992-02-11, under 510(k) number K915349.

Who is the listed applicant for PTA BALLOON CATHETER?

The FDA 510(k) record lists Schneider Intl., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PTA BALLOON CATHETER?

The FDA product code for PTA BALLOON CATHETER is LIT.

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Other records listing Schneider Intl., Ltd. as applicant

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K925406BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEMK931577SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWIK926003SCHNEIDER SOFTIP SST ANGIOGRAPHIC (DIAG) CATHETERK926271SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIOK925804SCHNEIDER HYDRO-SIL GUIDEWIREK924591SCHNEIDER SOLID-7 SOPTIP GUIDING CATHETER

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Related Devices (Code: 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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