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FDA 510(k)

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER

K-Number: K021735 · 2002-08-08

ApplicantBoston Scientific Scimed, Inc.
Decision Date2002-08-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 2002-08-08 under 510(k) number K021735. 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 BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER?

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER is a medical device that received FDA 510(k) clearance on 2002-08-08. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K021735.

When did BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER receive FDA 510(k) clearance?

BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER received FDA 510(k) clearance on 2002-08-08, under 510(k) number K021735.

Who is the listed applicant for BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER?

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

What is the FDA product code for BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER?

The FDA product code for BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER is DQY.

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Other records listing Boston Scientific Scimed, Inc. as applicant

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Related Devices (Code: DQY)

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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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