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FDA 510(k)

FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM

K-Number: K121175 · 2012-06-29

ApplicantOstial Corporation
Decision Date2012-06-29
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM is the device name listed in this FDA 510(k) record. The listed applicant is Ostial Corporation. It received FDA 510(k) clearance on 2012-06-29 under 510(k) number K121175. 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 FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM?

FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM is a medical device that received FDA 510(k) clearance on 2012-06-29. The listed applicant is Ostial Corporation. The 510(k) number is K121175.

When did FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM receive FDA 510(k) clearance?

FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM received FDA 510(k) clearance on 2012-06-29, under 510(k) number K121175.

Who is the listed applicant for FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM?

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

What is the FDA product code for FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM?

The FDA product code for FLASH PTA BALLON DILATATION CATHETER-5MM X 19MM X 135CM is LIT.

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Other records listing Ostial Corporation 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.

K152485FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cmK131450FLASH MINI OSTIAL SYSTEM - 3.0MM X 135CM, FLASH MINI OSTIAL SYSTEM - 3.5MM X 8MM X 135CM, FLASH MINI OSTIAL SYSTEM - 4.0K122178FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1K122379FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CMK113775FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MMK113582ARCHSTENT BILIARY SYSTEM

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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