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FDA 510(k)

INTRODUCER SHEATH AND DILATOR

K-Number: K971165 · 1997-07-23

ApplicantBoston Scientific Corp
Decision Date1997-07-23
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRODUCER SHEATH AND DILATOR 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 1997-07-23 under 510(k) number K971165. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODUCER SHEATH AND DILATOR?

INTRODUCER SHEATH AND DILATOR is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Boston Scientific Corp. The 510(k) number is K971165.

When did INTRODUCER SHEATH AND DILATOR receive FDA 510(k) clearance?

INTRODUCER SHEATH AND DILATOR received FDA 510(k) clearance on 1997-07-23, under 510(k) number K971165.

Who is the listed applicant for INTRODUCER SHEATH AND DILATOR?

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 INTRODUCER SHEATH AND DILATOR?

The FDA product code for INTRODUCER SHEATH AND DILATOR is LDF.

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Related Devices (Code: LDF)

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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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