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FDA 510(k)

PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM

K-Number: K052038 · 2005-08-16

ApplicantBoston Scientific Corporation
Decision Date2005-08-16
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K052038. 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 PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM?

PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Boston Scientific Corporation. The 510(k) number is K052038.

When did PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM receive FDA 510(k) clearance?

PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM received FDA 510(k) clearance on 2005-08-16, under 510(k) number K052038.

Who is the listed applicant for PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM?

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

What is the FDA product code for PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM?

The FDA product code for PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM 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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