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FDA 510(k)

BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA

K-Number: K000570 · 2000-04-13

ApplicantBoston Scientific Corp
Decision Date2000-04-13
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2000-04-13 under 510(k) number K000570. 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 BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA?

BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA is a medical device that received FDA 510(k) clearance on 2000-04-13. The listed applicant is Boston Scientific Corp. The 510(k) number is K000570.

When did BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA receive FDA 510(k) clearance?

BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA received FDA 510(k) clearance on 2000-04-13, under 510(k) number K000570.

Who is the listed applicant for BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA?

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

What is the FDA product code for BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA?

The FDA product code for BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA 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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